A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.
NCT Number: NCT06496893
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pre Diabetes|Type2 Diabetes Mellitus
Interventions: DIETARY_SUPPLEMENT: IP 1200 mg per soft gel capsule|DIETARY_SUPPLEMENT: Placebo Comparator: Placebo 1200 mg per soft gel capsule
Sponsor: Vedic Lifesciences Pvt. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-12-30
Locations: Shourya clinic, Pune, Maharashta, India|Shri balaji Multispeciality hospital,, Thāne, Maharashtra, 421503, India|Dr.Govinds Clinic,, Jaipur, Rajashthan, 302033, India|Upendra Medicare, Varanasi, Uttar Pradesh, 221001, India|Arihant Hospital, Varanasi, Uttar Pradesh, 221011, India

Summary:
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.

Primary Outcome Measures: 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, Screening visit (The same value will be considered for baseline) and Day 90.
Secondary Outcome Measures: 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, Screening visit (The same value will be considered for baseline) and Day 90.|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, Screening visit (The same value will be considered for baseline) and Day 90.|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., Day 0, Day 30, Day 60, Day 90|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, Day 0, Day 30, Day 60, Day 90|Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in central obesity as assessed by the change in the anthropometric index of waist-to-height ratio, The waist circumference standardization should be conducted for the observer. Two measurements will be conducted for waist circumference and height. If the variance between the two readings is within ± 1 cm, a third measurement will be obtained. Similarly, two measurements will be taken for weight, and if the difference falls within ± 200 grams, a third measurement will be taken., Day 0, Day 30, Day 60, Day 90|Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in Fasting Blood Glucose (FBG), FBG measures blood sugar after an overnight fast. A fasting blood sugar level of 99 mg/dL or lower is normal, 100 to 125 mg/dL indicates prediabetes, and 126 mg/dL or higher indicates diabetes., Day 0, Day 30, Day 60, Day 90|Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in Quality of life as assessed by SF- 6Dv2TM Health Survey, The quality of life will be assessed by SF- 6Dv2TM Health Survey. It is based on 6 health domains

1. Physical functioning 2. Role functioning 3. Pain 4. Vitality 5. Social functioning 6. Mental health The quality of life of the participants will be analysed domain wise. Each domain will be rated from 0 to 5, 0 being worst and 5 being the best state., Day 0, Day 30, Day 60, Day 90|Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in the Eating behavior as assessed by Three factor eating questionnaire - Revised 18, The raw scale scores are to be transformed to a 0-100 scale \[((raw score - lowest possible raw score)/possible raw score range) × 100\]. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating, Day 0, Day 30, Day 60, Day 90|To assess the effect of Investigational product (IP) on:Lipid profile [total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides], Insulin resistance, often associated with metabolic syndrome, can affect lipid metabolism. It may lead to increased levels of triglycerides and alterations in the balance of LDL and HDL cholesterol. High triglyceride levels are a common feature of metabolic syndrome. Excess calorie intake, especially from refined carbohydrates, can contribute to elevated triglycerides., Screening visit (The same value will be considered for baseline) and Day 90.