NEO-INULIN
(01)
MEDICAL TECHNOLOGY
Method of integral assessment of Dynamics of metabolic disorders in patients with type 2 diabetes mellitus during therapy with the dietary supplement "Neo-Inulin".
Abstract
The presented medical technology is a way of therapy of diabetes mellitus type 2 with expansion of the arsenal of means contributing to normalisation of glycaemia, improvement of blood lipid profile, restoration of endothelium and normalisation of microcirculation. Neo Inulin" is one of such remedies. The medical technology is intended for endocrinologists, therapists, general family practice doctors of medical institutions and medical and sanitary units, as well as for researchers.
Developing organisation: Federal State Budgetary Scientific Institution "East Siberian Institute of Medical and Ecological Research" Address: 3, 12-a microdistrict, Angarsk, 665826.
Authors of the medical technology: E.V. Katamanova - chief physician of the clinic of FGBNU VSIMEI, Doctor of medical sciences, associate professor; E.A. Beigel - deputy chief physician for medical part of FGBNU VSIMEI; associate professor of the department of occupational pathology and hygiene of IGMAPO - branch of FGBOU DPO RMANPO of the Ministry of Health of Russia, Candidate of medical sciences; N.G. Kuptsova - doctor of functional diagnostics of FGBNU VSIMEI.
Organisation for which permission is granted: Federal State Budgetary Scientific Institution "East Siberian Institute of Medical and Ecological Research".
Reviewers:
Shpagina L.A. - Doctor of Medical Sciences Professor, Head of the Department of Hospital Therapy and Medical Rehabilitation FGBOU VO Novosibirsk State Medical University Chief Physician, "State Budgetary Health Care Institution of Novosibirsk Region "City Clinical Hospital No. 2" Novosibirsk;
Description of Sections of Medical Technology:
Introduction.
Indications and contraindications to the use of the new medical technology.
Material and technical support of the new medical technology.
Description of medical technology.
Possible complications and ways of their elimination.
Effectiveness of the use of medical technology.
Expected effect of implementation.
List of literature.
Appendix.
List of abbreviations and designations:
AH - arterial hypertension
DKV - dihydroquercetin
DE - endothelial dysfunction
PAD - peripheral arterial disease
LDF - laser Doppler flowmetry
LPI - ankle brachial systolic pressure index
LEC - local ethics committee
MAU - microalbumin
DM - diabetes mellitus
SCF - glomerular filtration rate
HbA1c - glycated haemoglobin
Introduction
The medical technology "Method of integral assessment of the dynamics of metabolic disorders in patients with type 2 diabetes mellitus during therapy with Neo Inulin dietary supplement" is new and is being offered for the first time in the Russian Federation.
According to the data of the World Health Organisation for 2018, 425 million patients with diabetes mellitus (DM) are registered in the world. As the life expectancy of the population increases, the number of such patients is also growing. Among all causes of hyperglycaemia, type 2 diabetes mellitus (DM) holds the leading position. The incidence of type 2 diabetes is growing catastrophically in all countries of the world without exception, and every 15-20 years the total number of patients with diabetes doubles. Glucose elevation is accompanied by visceral obesity, arterial hypertension (AH), increased low-density lipoproteins, triglycerides and decreased high-density lipoproteins. In this regard, when determining the treatment tactics of type 2 DM, concomitant hyperglycaemia disorders or their clinical outcomes should be taken into account. The main complication of DM is microangiopathy, endothelial damage by excessive content of glycated blood proteins [Morgunov L.Y. Flash glucose monitoring in patients with diabetes: simple, convenient, necessary // Endocrinology: news, opinions, training. 2021. Т. 10, № 4. C. 69-78. DOI: https://doi.org/10.33029/2304-9529-2021-10-4-69-78; Fokkert M.J., Damman A., van Dijk P.R., Edens M.A., Abbes S., Braakman J. et al. Use of FreeStyle Libre Flash Monitor Register in the Netherlands (FLARE-NL1): patient experiences, satisfaction, and cost analysis // Int. J. Endocrinol. 2019. Vol. 2019. Article ID 4649303. DOI: https://doi.org/10.1155/2019/4649303 ].
Therefore, it is highly relevant to search for new drugs that contribute to the normalisation of glycaemia, improve blood lipid profile, restore endothelium and normalise microcirculation. Such means include the preparation "Neo Inulin", containing in 1 capsule: inulin - 184 mg, dihydroquercetin - 40 mg, lipoic acid - 30 mg, chromium - 0.05 mg, bilberry shoot extract - 44 mg, having hypoglycaemic, antioxidant, hepatoprotective effect, stimulating effect on tissue blood flow, stabilising the barrier function of microvessels, reducing the permeability of capillary walls and thus contributing to the reduction of congestion in the microcirculatory bed and endothelium restoration. [Ahmed W., Rashid S. Functional and therapeutic potential of inulin: A comprehensive review // Crit. Rev. Food. Sci Nutr. - 2019. – Vol. 59, №1. – Р. 1-13. doi: 10.1080/10408398.2017.1355775. Epub 2017 Oct 11.
2. Gao T., Jiao Y., Liu Y. at all. Protective Effects of Konjac and Inulin Extracts on Type 1 and Type 2 // J. Diabetes. Diabetes Res. - 2019. - № 7. –Р. 382-387. doi: 10.1155/2019/3872182. eCollection 2019.
3.Wan X., Guo H., Liang Y. at all. The physiological functions and pharmaceutical applications of inulin: A review // Carbohydr Polym. – 2020. - № 15. – Р.246. doi: 10.1016/j.carbpol.2020.116589. Epub 2020 Jun 11.
4.Sunil C., Xu B. Phytochemistry. An insight into the health-promoting effects of taxifolin (dihydroquercetin) // J. phytochem. - 2019. – 166 р. doi:10.1016 /j.phytochem.2019.112066. Epub 2019 Jul 17.
5. Shu Z., Yang Y., Yang L. at all. Cardioprotective effects of dihydroquercetin against ischemia reperfusion injury by inhibiting oxidative stress and endoplasmic reticulum stress-induced apoptosis via the PI3K/Akt pathway // Food Funct. – 2019. - Vol.10. - №1. – Р. 203-215. doi: 10.1039/c8fo01256c.
6.Zhang Y., Yu J., Dong X.D., Ji H.Y. Research on Characteristics, Antioxidant and Antitumor Activities of Dihydroquercetin and Its Complexes // Molecules. – 2017. - Vol.23. – Р.20. doi: 10.3390/molecules23010020].
Thus, in the treatment of diabetes mellitus, a complex of therapeutic measures is used, including basic drug therapy and additional multidirectional drugs that affect oxidative stress, endothelial function, regeneration, metabolic processes of the nervous system and, finally, on the glucose metabolism itself in patients with DM [Ametov A.S., Kosyan A.A. Role and place of disturbed redox balance in the development of diabetic neuropathy and antioxidant effects of alpha-lipoic acid // Endocrinology: news, opinions, training. 2020. Т. 9, № 2. C. 70-79. DOI: https://doi.org/10.33029/2304-9529-2020-9-2-70-79].
Administration of the bioflavonoid antioxidant dihydroquercetin during prolonged experimental hyperglycaemia decreases blood glucose level, the content of POL products and dystrophic changes in β-insulocytes. Against this background, the number of cells in islets and the number of specific β-granules in them increases. The level of pathological changes and intensity of reaction to SHIK-positive substances in connective tissue and in blood vessels of pancreatic islets decreases [Dihydroquercetin and its effectiveness in long-term experimental hyperglycemia. Journal of Health. Medical Ecology. Science. 1 (44) - 2011 - С.92-95].
Most of the additional drugs used today have one direction of action, therefore, we applied "Neo inulin", affecting all the above links of the pathogenesis of diabetes mellitus.
The proposed method was developed during a clinical study of the effectiveness of "Neo inulin" in the complex treatment of patients with type 2 diabetes mellitus. A total of 18 women, mean age 64.5±8.7 years, mean weight 77.8±11.4 kg and 3 men, mean age 54.6±12.4 years, mean body weight 114±40.2 kg participated in the study. The mean duration of diabetes mellitus was 11.0(7.0-12.0) years.
All patients were examined to calculate an integral index to assess the dynamics of metabolic disorders (before and after treatment), including blood chemistry, including creatinine, glycated haemoglobin, glycated haemoglobin, MAU, CKF, glucose levels. Ankle-shoulder systolic blood pressure index (ABPI) was calculated as the ratio of systolic blood pressure (SBP) measured at the ankle and shoulder.
All patients were divided into 3 groups according to the results of the examination and the calculation of the integral index:
The first - interval boundaries of metabolic disorders within the range up to 7.32 (weakly expressed).
The second group - interval boundaries of metabolic disorders within the limits of 7.32-8.71 (moderately expressed).
The third group - the limits of intervals of metabolic disorders more than 8.71m (significant degree of severity).
"Neo inulin" was prescribed 2 capsules per day, for 12 weeks. "Neo inulin" was used in the complex of basic therapy of diabetes mellitus.
The comparison group consisted of 21 people. 16 women mean age 71.1±6.4 years, mean weight 83.7±9.3 kg and 7 men, mean age 59.8±11.1 years, mean body weight 98±36.4 kg. The mean duration of diabetes mellitus was 13.0 (6.0-15.0) years. All received baseline sugar-lowering therapy, with no additional inclusion of Neo-Inulin.
Indications for the use of medical technology
The present method is used to assess metabolic disorders in DM and expand the possibilities of therapy of type 2 diabetes mellitus. The developed treatment method can be used in outpatient and inpatient settings for personalised therapy of DM.
Indication for the use of medical technology
Patients with DM who are continuously taking sugar-lowering therapy.
Contraindications to the use of medical technology:
1. Pregnancy and breastfeeding period;
2. Decompensation of cerebrovascular diseases, cardiovascular diseases, malignant tumours, kidney diseases, liver diseases, thyroid diseases, active tuberculosis or other infectious diseases;
3. Dependence on drugs or alcohol;
4. Taking systemic steroid therapy or immunosuppressive therapy;
5. Presence of sensitisation and hypersensitivity to the components of dietary supplements.
Material and technical support of medical technology
The studies were performed with informed consent of patients and comply with the ethical standards of the Declaration of Helsinki (2000) and the order of the Ministry of Health of the Russian Federation № 266 (19.06.2003)
For the study are necessary:
Several disposable tubes of vacuum systems Vassette in the amount of 11 ml are needed for venous blood collection for conducting studies on the content of biochemical indicators characterising the state of the vascular wall and genetic studies (creatinine, glycated haemoglobin, MAU, SCF, glucose).
The device "LAKK-01" - laser analyser for assessment of blood microcirculation.
Description of medical technology:
Patient examination
The diagnosis of DM is established on the basis of a combination of two laboratory indicators corresponding to the diagnostic criteria of DM:
fasting blood glucose (two analyses performed on different days);
fasting blood glucose and HbA1c;
fasting blood glucose and 2 hours after a 75 g glucose load or
blood glucose in a random assay in the presence of classic symptoms of hyperglycaemia or dehydration and catabolism.
When hyperglycemia is first detected against the background of a critical condition, HbA1c should be assessed to establish the diagnosis: an HbA1c level >6.5% indicates in favour of DM.
Blood biochemical examination was performed, including determination of creatinine, glycated haemoglobin, MAU, CKF, glucose levels. Venous blood was collected using several disposable tubes of vacuum systems Vasscete in the amount of 11 ml for biochemical parameters characterising the state of the vascular wall and genetic studies. The calculations were guided by the following normative indicators:
MAU - daily norm - Less than 30 mg/day, morning average urine portion - less than 20 mg/litre
Blood glucose - 3.5-5.7 mmol/l - norm for adults; In elderly people and in pregnancy glucose is normal - 3.3-6.5 mmol/l.
Glycated haemoglobin - The recommended glycated haemoglobin level in people with diabetes is less than 7%.
The CKD-EPI CKD in women is considered to be 70 to 130 ml/min as optimal values. The norm in men is from 90 to 145 ml/min.
Blood creatinine - Women: 44.0-80.0 µmol/l, Men: 74.0-110.0 µmol/l;
Timing of the study: during the examination period.
Possible risks and inconveniences: after blood collection it is possible to develop subcutaneous haematoma - haemorrhage into soft tissues at the venipuncture site; development of phlebitis - inflammation of the vein at the venipuncture site (signs: pain, thickening, hyperaemia along the course of the vein); nerve damage as a result of its injection or compression due to haematoma formation; inflammatory phenomena of soft tissues at the venipuncture site - infiltrate, abscess, skin necrosis (extracts from Instruction No. 2. 1.3.007-02 dated 10 October 2002).
The following were assessed:
- Demographic characteristics of patients (age, sex, height and body weight);
Methods of microcirculation assessment
Laser Doppler Flowmetry (LDF) is a method of determining the functional characterisation of tissue blood flow. LDF is performed using devices designed for this purpose. We evaluated microcirculation indices using the device "LAKK-01" - laser analyser for blood microcirculation evaluation, manufactured by LLC SPE "LAZMA". LDF method is based on optical non-invasive probing of tissues by laser radiation and analysis of scattered and reflected radiation from erythrocytes moving in tissues.
M - arithmetic mean value of the microcirculation index registered in the same time interval (σ)
Kv - coefficient of variation of microcirculation flow
σ - mean-square deviation of perfusion fluctuations, mean blood flow modulation.
Statistical processing was performed using the software package STATISTICA - version 6 by Stat Soft Inc. (USA).
To assess the effectiveness of therapy, an integral index of metabolic disorders severity was developed based on the data of clinical examination of patients.
Stages of calculation and evaluation of the integral indicator:
Selection of indicator indicators, which were blood glucose level, glycated haemoglobin, creatinine, CKF, Kv - coefficient of variation of micro blood flow.
Conversion of these indices to normalised- ratio of patient's result to reference values.
Using the formula 2,113208*Ai+2,92*Bi+2,028571*Ci+2,9375*Di-3,5*Ei calculation of the integral index of metabolic changes, with the subsequent assignment of the patient to one of three groups, where
Ai - normalised glycated haemoglobin
Bi - normalised blood glucose index
Ci - normalised blood creatinine index
Di - normalised index of SCF
Ei - normalised Kv
Clinical examples:
Consider the patients coded 1 in the group, with the use of "Neo Inulin" and coded 2 from the comparison group. The results of examination by informative signs are presented in Table 1.
Example 1
Patient S, age 57 years, duration of DM 12 years.Using the formula 2,113208*Ai+2,92*Bi+2,028571*Ci+2,9375*Di-3,5*Ei we calculate the integral index of metabolic changes before treatment: 2,113208*1,08+2,92*1,72+2,028571*1,11+2,9375*0,65+3,5*0,86 =14,47 (pronounced metabolic disorders).Using the formula 2.113208*Ai+2.92*Bi+2.028571*Ci+2.9375*Di-3.5*Ei we calculate the integral index of metabolic changes after treatment: 2.113208*0.87+2.92*1.27+2.028571*1+2.9375*0.74+3.5*1 =2.113208*0.87+2.92*1.27+2.028571*1+2.9375*0.74+3.5*1
Possible complications and ways of their elimination:
When implementing Neo Inulin therapy in patients with type 2 DM, false positive and/or false negative results are possible.Therefore, an individualised approach is required in each case.Factors that may influence the results of the study:Recent viral and/or bacterial infections, surgical interventions.Intake of medications.To establish these factors, contraindications to the use of medical technology were clarified.
Effectiveness of the use of medical technology:After completion of a 2-month course of therapy with the dietary supplement "Neo-Inulin" the following results were obtained:
All patients of the third group (with significant violations of metabolic status) moved to the first and second groups (with less pronounced violations).
Expected effect from implementationThe proposed method of therapy is an opportunity to expand the arsenal of drugs in the treatment of patients with DM, in particular "Neo-Inulin", focused on the obtained statistically significant indicators.The method makes it possible to objectively assess the effectiveness of the use of supplementary to the main therapy of DM "Neo-Inulin" and allows to personalise treatment measures aimed at preserving the health and longevity of the population.Application of the treatment scheme including "Neo-Inulin" contributes to the increase in the values of health-related quality of life assessments, as well as to the increase in the level of psychosocial adaptation, treatment efficiency and improvement of the quality of life.Positive dynamics on the background of treatment with "Neo-Inulin" was noted in terms of glycated haemoglobin, fasting glucose, kidney function indicators (creatinine and CKF), as well as improvement of microcirculation.In order to improve the effectiveness of rehabilitation of patients with diabetes, it is recommended to prescribe "Neo Inulin" in a dose of 1 capsule in the morning and evening with meals for 3 months.To consolidate the achieved result of rehabilitation, it is recommended to repeat courses of "Neo Inulin" 3 times a year for 2 months.
Abstract
The presented medical technology is a way of therapy of diabetes mellitus type 2 with expansion of the arsenal of means contributing to normalisation of glycaemia, improvement of blood lipid profile, restoration of endothelium and normalisation of microcirculation. Neo Inulin" is one of such remedies. The medical technology is intended for endocrinologists, therapists, general family practice doctors of medical institutions and medical and sanitary units, as well as for researchers.
Developing organisation: Federal State Budgetary Scientific Institution "East Siberian Institute of Medical and Ecological Research" Address: 3, 12-a microdistrict, Angarsk, 665826.
Authors of the medical technology: E.V. Katamanova - chief physician of the clinic of FGBNU VSIMEI, Doctor of medical sciences, associate professor; E.A. Beigel - deputy chief physician for medical part of FGBNU VSIMEI; associate professor of the department of occupational pathology and hygiene of IGMAPO - branch of FGBOU DPO RMANPO of the Ministry of Health of Russia, Candidate of medical sciences; N.G. Kuptsova - doctor of functional diagnostics of FGBNU VSIMEI.
Organisation for which permission is granted: Federal State Budgetary Scientific Institution "East Siberian Institute of Medical and Ecological Research".
Reviewers:
Shpagina L.A. - Doctor of Medical Sciences Professor, Head of the Department of Hospital Therapy and Medical Rehabilitation FGBOU VO Novosibirsk State Medical University Chief Physician, "State Budgetary Health Care Institution of Novosibirsk Region "City Clinical Hospital No. 2" Novosibirsk;
Description of Sections of Medical Technology:
Introduction.
Indications and contraindications to the use of the new medical technology.
Material and technical support of the new medical technology.
Description of medical technology.
Possible complications and ways of their elimination.
Effectiveness of the use of medical technology.
Expected effect of implementation.
List of literature.
Appendix.
List of abbreviations and designations:
AH - arterial hypertension
DKV - dihydroquercetin
DE - endothelial dysfunction
PAD - peripheral arterial disease
LDF - laser Doppler flowmetry
LPI - ankle brachial systolic pressure index
LEC - local ethics committee
MAU - microalbumin
DM - diabetes mellitus
SCF - glomerular filtration rate
HbA1c - glycated haemoglobin
Introduction
The medical technology "Method of integral assessment of the dynamics of metabolic disorders in patients with type 2 diabetes mellitus during therapy with Neo Inulin dietary supplement" is new and is being offered for the first time in the Russian Federation.
According to the data of the World Health Organisation for 2018, 425 million patients with diabetes mellitus (DM) are registered in the world. As the life expectancy of the population increases, the number of such patients is also growing. Among all causes of hyperglycaemia, type 2 diabetes mellitus (DM) holds the leading position. The incidence of type 2 diabetes is growing catastrophically in all countries of the world without exception, and every 15-20 years the total number of patients with diabetes doubles. Glucose elevation is accompanied by visceral obesity, arterial hypertension (AH), increased low-density lipoproteins, triglycerides and decreased high-density lipoproteins. In this regard, when determining the treatment tactics of type 2 DM, concomitant hyperglycaemia disorders or their clinical outcomes should be taken into account. The main complication of DM is microangiopathy, endothelial damage by excessive content of glycated blood proteins [Morgunov L.Y. Flash glucose monitoring in patients with diabetes: simple, convenient, necessary // Endocrinology: news, opinions, training. 2021. Т. 10, № 4. C. 69-78. DOI: https://doi.org/10.33029/2304-9529-2021-10-4-69-78; Fokkert M.J., Damman A., van Dijk P.R., Edens M.A., Abbes S., Braakman J. et al. Use of FreeStyle Libre Flash Monitor Register in the Netherlands (FLARE-NL1): patient experiences, satisfaction, and cost analysis // Int. J. Endocrinol. 2019. Vol. 2019. Article ID 4649303. DOI: https://doi.org/10.1155/2019/4649303 ].
Therefore, it is highly relevant to search for new drugs that contribute to the normalisation of glycaemia, improve blood lipid profile, restore endothelium and normalise microcirculation. Such means include the preparation "Neo Inulin", containing in 1 capsule: inulin - 184 mg, dihydroquercetin - 40 mg, lipoic acid - 30 mg, chromium - 0.05 mg, bilberry shoot extract - 44 mg, having hypoglycaemic, antioxidant, hepatoprotective effect, stimulating effect on tissue blood flow, stabilising the barrier function of microvessels, reducing the permeability of capillary walls and thus contributing to the reduction of congestion in the microcirculatory bed and endothelium restoration. [Ahmed W., Rashid S. Functional and therapeutic potential of inulin: A comprehensive review // Crit. Rev. Food. Sci Nutr. - 2019. – Vol. 59, №1. – Р. 1-13. doi: 10.1080/10408398.2017.1355775. Epub 2017 Oct 11.
2. Gao T., Jiao Y., Liu Y. at all. Protective Effects of Konjac and Inulin Extracts on Type 1 and Type 2 // J. Diabetes. Diabetes Res. - 2019. - № 7. –Р. 382-387. doi: 10.1155/2019/3872182. eCollection 2019.
3.Wan X., Guo H., Liang Y. at all. The physiological functions and pharmaceutical applications of inulin: A review // Carbohydr Polym. – 2020. - № 15. – Р.246. doi: 10.1016/j.carbpol.2020.116589. Epub 2020 Jun 11.
4.Sunil C., Xu B. Phytochemistry. An insight into the health-promoting effects of taxifolin (dihydroquercetin) // J. phytochem. - 2019. – 166 р. doi:10.1016 /j.phytochem.2019.112066. Epub 2019 Jul 17.
5. Shu Z., Yang Y., Yang L. at all. Cardioprotective effects of dihydroquercetin against ischemia reperfusion injury by inhibiting oxidative stress and endoplasmic reticulum stress-induced apoptosis via the PI3K/Akt pathway // Food Funct. – 2019. - Vol.10. - №1. – Р. 203-215. doi: 10.1039/c8fo01256c.
6.Zhang Y., Yu J., Dong X.D., Ji H.Y. Research on Characteristics, Antioxidant and Antitumor Activities of Dihydroquercetin and Its Complexes // Molecules. – 2017. - Vol.23. – Р.20. doi: 10.3390/molecules23010020].
Thus, in the treatment of diabetes mellitus, a complex of therapeutic measures is used, including basic drug therapy and additional multidirectional drugs that affect oxidative stress, endothelial function, regeneration, metabolic processes of the nervous system and, finally, on the glucose metabolism itself in patients with DM [Ametov A.S., Kosyan A.A. Role and place of disturbed redox balance in the development of diabetic neuropathy and antioxidant effects of alpha-lipoic acid // Endocrinology: news, opinions, training. 2020. Т. 9, № 2. C. 70-79. DOI: https://doi.org/10.33029/2304-9529-2020-9-2-70-79].
Administration of the bioflavonoid antioxidant dihydroquercetin during prolonged experimental hyperglycaemia decreases blood glucose level, the content of POL products and dystrophic changes in β-insulocytes. Against this background, the number of cells in islets and the number of specific β-granules in them increases. The level of pathological changes and intensity of reaction to SHIK-positive substances in connective tissue and in blood vessels of pancreatic islets decreases [Dihydroquercetin and its effectiveness in long-term experimental hyperglycemia. Journal of Health. Medical Ecology. Science. 1 (44) - 2011 - С.92-95].
Most of the additional drugs used today have one direction of action, therefore, we applied "Neo inulin", affecting all the above links of the pathogenesis of diabetes mellitus.
The proposed method was developed during a clinical study of the effectiveness of "Neo inulin" in the complex treatment of patients with type 2 diabetes mellitus. A total of 18 women, mean age 64.5±8.7 years, mean weight 77.8±11.4 kg and 3 men, mean age 54.6±12.4 years, mean body weight 114±40.2 kg participated in the study. The mean duration of diabetes mellitus was 11.0(7.0-12.0) years.
All patients were examined to calculate an integral index to assess the dynamics of metabolic disorders (before and after treatment), including blood chemistry, including creatinine, glycated haemoglobin, glycated haemoglobin, MAU, CKF, glucose levels. Ankle-shoulder systolic blood pressure index (ABPI) was calculated as the ratio of systolic blood pressure (SBP) measured at the ankle and shoulder.
All patients were divided into 3 groups according to the results of the examination and the calculation of the integral index:
The first - interval boundaries of metabolic disorders within the range up to 7.32 (weakly expressed).
The second group - interval boundaries of metabolic disorders within the limits of 7.32-8.71 (moderately expressed).
The third group - the limits of intervals of metabolic disorders more than 8.71m (significant degree of severity).
"Neo inulin" was prescribed 2 capsules per day, for 12 weeks. "Neo inulin" was used in the complex of basic therapy of diabetes mellitus.
The comparison group consisted of 21 people. 16 women mean age 71.1±6.4 years, mean weight 83.7±9.3 kg and 7 men, mean age 59.8±11.1 years, mean body weight 98±36.4 kg. The mean duration of diabetes mellitus was 13.0 (6.0-15.0) years. All received baseline sugar-lowering therapy, with no additional inclusion of Neo-Inulin.
Indications for the use of medical technology
The present method is used to assess metabolic disorders in DM and expand the possibilities of therapy of type 2 diabetes mellitus. The developed treatment method can be used in outpatient and inpatient settings for personalised therapy of DM.
Indication for the use of medical technology
Patients with DM who are continuously taking sugar-lowering therapy.
Contraindications to the use of medical technology:
1. Pregnancy and breastfeeding period;
2. Decompensation of cerebrovascular diseases, cardiovascular diseases, malignant tumours, kidney diseases, liver diseases, thyroid diseases, active tuberculosis or other infectious diseases;
3. Dependence on drugs or alcohol;
4. Taking systemic steroid therapy or immunosuppressive therapy;
5. Presence of sensitisation and hypersensitivity to the components of dietary supplements.
Material and technical support of medical technology
The studies were performed with informed consent of patients and comply with the ethical standards of the Declaration of Helsinki (2000) and the order of the Ministry of Health of the Russian Federation № 266 (19.06.2003)
For the study are necessary:
Several disposable tubes of vacuum systems Vassette in the amount of 11 ml are needed for venous blood collection for conducting studies on the content of biochemical indicators characterising the state of the vascular wall and genetic studies (creatinine, glycated haemoglobin, MAU, SCF, glucose).
The device "LAKK-01" - laser analyser for assessment of blood microcirculation.
Description of medical technology:
Patient examination
The diagnosis of DM is established on the basis of a combination of two laboratory indicators corresponding to the diagnostic criteria of DM:
fasting blood glucose (two analyses performed on different days);
fasting blood glucose and HbA1c;
fasting blood glucose and 2 hours after a 75 g glucose load or
blood glucose in a random assay in the presence of classic symptoms of hyperglycaemia or dehydration and catabolism.
When hyperglycemia is first detected against the background of a critical condition, HbA1c should be assessed to establish the diagnosis: an HbA1c level >6.5% indicates in favour of DM.
Blood biochemical examination was performed, including determination of creatinine, glycated haemoglobin, MAU, CKF, glucose levels. Venous blood was collected using several disposable tubes of vacuum systems Vasscete in the amount of 11 ml for biochemical parameters characterising the state of the vascular wall and genetic studies. The calculations were guided by the following normative indicators:
MAU - daily norm - Less than 30 mg/day, morning average urine portion - less than 20 mg/litre
Blood glucose - 3.5-5.7 mmol/l - norm for adults; In elderly people and in pregnancy glucose is normal - 3.3-6.5 mmol/l.
Glycated haemoglobin - The recommended glycated haemoglobin level in people with diabetes is less than 7%.
The CKD-EPI CKD in women is considered to be 70 to 130 ml/min as optimal values. The norm in men is from 90 to 145 ml/min.
Blood creatinine - Women: 44.0-80.0 µmol/l, Men: 74.0-110.0 µmol/l;
Timing of the study: during the examination period.
Possible risks and inconveniences: after blood collection it is possible to develop subcutaneous haematoma - haemorrhage into soft tissues at the venipuncture site; development of phlebitis - inflammation of the vein at the venipuncture site (signs: pain, thickening, hyperaemia along the course of the vein); nerve damage as a result of its injection or compression due to haematoma formation; inflammatory phenomena of soft tissues at the venipuncture site - infiltrate, abscess, skin necrosis (extracts from Instruction No. 2. 1.3.007-02 dated 10 October 2002).
The following were assessed:
- Demographic characteristics of patients (age, sex, height and body weight);
Methods of microcirculation assessment
Laser Doppler Flowmetry (LDF) is a method of determining the functional characterisation of tissue blood flow. LDF is performed using devices designed for this purpose. We evaluated microcirculation indices using the device "LAKK-01" - laser analyser for blood microcirculation evaluation, manufactured by LLC SPE "LAZMA". LDF method is based on optical non-invasive probing of tissues by laser radiation and analysis of scattered and reflected radiation from erythrocytes moving in tissues.
M - arithmetic mean value of the microcirculation index registered in the same time interval (σ)
Kv - coefficient of variation of microcirculation flow
σ - mean-square deviation of perfusion fluctuations, mean blood flow modulation.
Statistical processing was performed using the software package STATISTICA - version 6 by Stat Soft Inc. (USA).
To assess the effectiveness of therapy, an integral index of metabolic disorders severity was developed based on the data of clinical examination of patients.
Stages of calculation and evaluation of the integral indicator:
Selection of indicator indicators, which were blood glucose level, glycated haemoglobin, creatinine, CKF, Kv - coefficient of variation of micro blood flow.
Conversion of these indices to normalised- ratio of patient's result to reference values.
Using the formula 2,113208*Ai+2,92*Bi+2,028571*Ci+2,9375*Di-3,5*Ei calculation of the integral index of metabolic changes, with the subsequent assignment of the patient to one of three groups, where
Ai - normalised glycated haemoglobin
Bi - normalised blood glucose index
Ci - normalised blood creatinine index
Di - normalised index of SCF
Ei - normalised Kv
Clinical examples:
Consider the patients coded 1 in the group, with the use of "Neo Inulin" and coded 2 from the comparison group. The results of examination by informative signs are presented in Table 1.
Example 1
Patient S, age 57 years, duration of DM 12 years.Using the formula 2,113208*Ai+2,92*Bi+2,028571*Ci+2,9375*Di-3,5*Ei we calculate the integral index of metabolic changes before treatment: 2,113208*1,08+2,92*1,72+2,028571*1,11+2,9375*0,65+3,5*0,86 =14,47 (pronounced metabolic disorders).Using the formula 2.113208*Ai+2.92*Bi+2.028571*Ci+2.9375*Di-3.5*Ei we calculate the integral index of metabolic changes after treatment: 2.113208*0.87+2.92*1.27+2.028571*1+2.9375*0.74+3.5*1 =2.113208*0.87+2.92*1.27+2.028571*1+2.9375*0.74+3.5*1
Possible complications and ways of their elimination:
When implementing Neo Inulin therapy in patients with type 2 DM, false positive and/or false negative results are possible.Therefore, an individualised approach is required in each case.Factors that may influence the results of the study:Recent viral and/or bacterial infections, surgical interventions.Intake of medications.To establish these factors, contraindications to the use of medical technology were clarified.
Effectiveness of the use of medical technology:After completion of a 2-month course of therapy with the dietary supplement "Neo-Inulin" the following results were obtained:
All patients of the third group (with significant violations of metabolic status) moved to the first and second groups (with less pronounced violations).
Expected effect from implementationThe proposed method of therapy is an opportunity to expand the arsenal of drugs in the treatment of patients with DM, in particular "Neo-Inulin", focused on the obtained statistically significant indicators.The method makes it possible to objectively assess the effectiveness of the use of supplementary to the main therapy of DM "Neo-Inulin" and allows to personalise treatment measures aimed at preserving the health and longevity of the population.Application of the treatment scheme including "Neo-Inulin" contributes to the increase in the values of health-related quality of life assessments, as well as to the increase in the level of psychosocial adaptation, treatment efficiency and improvement of the quality of life.Positive dynamics on the background of treatment with "Neo-Inulin" was noted in terms of glycated haemoglobin, fasting glucose, kidney function indicators (creatinine and CKF), as well as improvement of microcirculation.In order to improve the effectiveness of rehabilitation of patients with diabetes, it is recommended to prescribe "Neo Inulin" in a dose of 1 capsule in the morning and evening with meals for 3 months.To consolidate the achieved result of rehabilitation, it is recommended to repeat courses of "Neo Inulin" 3 times a year for 2 months.
