A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus.
Males and females of age more than equal to 30 years and less than equal to 70 years.
Body mass index within 30 kg/m2 and 35 kg/m2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).
Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg/dL to 199 mg/dL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg/dL to 125 mg/dL).
Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg/dL.
Individuals who are exclusively vegetarians diet.
Individuals with Type 1 diabetes mellitus.
Individuals with Type 2 diabetes mellitus on medication.
Individuals with any other endocrine disorder.
Parallel
IP 1200 mg per soft gel capsule
Dietary supplementTwo soft gels to be taken with breakfast and two soft gels to be taken with dinner
Placebo Comparator: Placebo 1200 mg per soft gel capsule
Dietary supplementTwo soft gels to be taken with breakfast and two soft gels to be taken with dinner
Cohort 2- (Type 2 diabetes mellitus (T2DM)) To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glycated haemoglobin (HbA1c) in individuals with Type 2 diabetes mellitus (T2DM).
HbA1c reference ranges for prediabetes is between 5.7 to 6.4% for type II diabetes mellitus, it is between 7 to 9%.. For the current study, impaired range of Hba1c from 6.5 to 6.9% shall be consider as prediabetes
Cohort 1- ( Pre-diabetes) To assess the effect of Investigational Product (IP) on blood sugar in Pre-diabetes as assessed by 2-hour plasma glucose level by Oral Glucose Tolerance Test
Oral glucose tolerance tests (OGTT) are used to measure how well the body can process a larger amount of sugar. If the blood sugar measured in the test is above a certain level, this could be a sign that sugar is not being absorbed enough by the body's cells. Diabetes or gestational diabetes might be at the root of this problem.As per American Diabetes Association, OGTT ranges for prediabetes individuals is 140 mg/ dL to 199 mg/dL and more than 200 mg/dl is considered as type II diabetes mellitus
Cohort 1- ( Pre-diabetes) To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glucose metabolism as assessed by change in the HbA1c
HbA1c reference ranges for prediabetes is between 5.7 to 6.4% for type II diabetes mellitus, it is between 7 to 9%.. For the current study, impaired range of Hba1c from 6.5 to 6.9% is also being considered as prediabetes
Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Pancreatic efficiency as assessed by the change in the fasting insulin
Normal fasting insulin levels range between 5 and 15 μU/mL.
Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Percentage change in body weight by weighing scale
Obesity is a chronic condition characterized by an excess of body fat. It is a complex disorder of appetite regulation and energy metabolism controlled by specific biological factors. There is strong evidence to suggest that the risks of mortality and morbidity associated with obesity can be reduced with weight loss
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
