Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation

Study Overview
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Brief Summary
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Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.

Detailed Description
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This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials. volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2. On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B. Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation. Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.

Official Title
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Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine

Conditions
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Diabetes Mellitus, Pre Diabetes

Intervention / Treatment
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* Dietary Supplement: Polyherbal formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-59 Impaired Fasting Glucose (100-125mg/dl) Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT History of Diabetes in first degree relation with one condition At high risk with BMI > 35% Early onset diabetic / accidental on screening (glucose >200mg/dl) Exclusion Criteria: on renal dialysis; an acute or terminal illness or serious mental illness; history of recent coronary event within the last 12 months; a recent history of acute medical problem or admission to hospital; any other severe medical conditions that need intervention / treatment has poor short-term prognosis (expected death in <2 years); is planning to travel for longer than 6 weeks during the 6-week intervention period; or is with compromised liver / kidney / cardiac function older patients of DM taking any form of medication / intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A Pre-diabetic placebo<br>Group of pre-diabetics receiving placebo BD for six weeks | |
| Group B Pre-diabetic test<br>Group of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks | Dietary Supplement: Polyherbal formulation<br>* Test candidate will be administered per oral before / with meal in two divided doses<br>|
| Group C Diabetic test<br>Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks | Dietary Supplement: Polyherbal formulation<br>* Test candidate will be administered per oral before / with meal in two divided doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose Tolerance (FGT) | enhancement of fasting glucose tolerance (<100mg/dl) | six weeks | 
| Glucose Tolerance (GT) | enhancement of oral glucose tolerance (<140mg/dl) | six weeks | 
| HB-A1c | improvement in glycated hemoglobin (HB-A1c) percentage <6%, | six week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile | serum Cholesterol level (mg/dl) | six weeks | 
| Lipid Profile | Serum Triglycerides (mg/dl) | Six Weeks | 
| Lipid Profile | Serum Low Density Lipids (LDL) (mg/dl) | Six week | 
| Lipid Profile | Serum High Density Lipids (HDL) (mg/dl) | six week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired Fasting Glucose, Impaired Glucose Tolerance, 2hr -75gm Oral Glucose Tolerance Test, Diabetes Mellitus Prevention