A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type2 Diabetes Mellitus; Pre Diabetes
• Intervention / Treatment: Dietary supplement: IP 1200 mg per soft gel capsule; Dietary supplement: Placebo Comparator: Placebo 1200 mg per soft gel capsule

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Shalini Srivastava,, MBBS, MD; Phone Number: 7738418890; Email: shalini.s@vediclifesciences.com
• Study Contact Backup: Name: Lalit Pawaskar, M.Pharm, PGDM; Phone Number: 7738418890; Email: lalit.p@vediclifesciences.com

Study Locations

• India
  • Maharashta
    • Pune, Maharashta, India
      • Shourya clinic
      • Contact: Dr. Nikhil More, MBBS MD; Phone Number: 8446512457; Email: nikhilmore8750@gmail.com
  • Maharashtra
    • Thāne, Maharashtra, India, 421503
      • Shri balaji Multispeciality hospital,
      • Contact: Dr. Hemant Ingole, MBBS, MD; Phone Number: 8600848920; Email: hemantingole11@gmail.com
  • Rajashthan
    • Jaipur, Rajashthan, India, 302033
      • Dr.Govinds Clinic,
      • Contact: Dr Govid Rankawat, MBBS MD; Phone Number: 7891368525; Email: drgovind.rankawat@gmail.com
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221001
      • Upendra Medicare
      • Contact: Dr. Gaurav Singh, MBBS MD; Phone Number: 9555112643; Email: drgauravsingh371@gmail.com
    • Varanasi, Uttar Pradesh, India, 221011
      • Arihant Hospital
      • Contact: Dr. Dilip Chaurasiya, MBBS,MD; Phone Number: 7292022991; Email: dilipchaurasiya250@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Males and females of age more than equal to 30 years and less than equal to 70 years.
2. 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).
3. 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).
4. 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.
5. Triglycerides between 150 mg/dL and 299 mg/dL (both values inclusive) and/or Low-Density Lipoprotein (LDL) in between 130 mg/dL and 189 mg/dL (both values inclusive).
6. Individuals having non-vegetarian diet for at least 2 days a week.
7. Non-smoker.
8. Individuals who are willing to not change their physical activity levels throughout the study period.
9. Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
10. Individuals ready to give voluntary, written informed consent to participate in the study.

Exclusion Criteria:

1. Individuals who are exclusively vegetarians diet.
2. Individuals with Type 1 diabetes mellitus.
3. Individuals with Type 2 diabetes mellitus on medication.
4. Individuals with any other endocrine disorder.
5. Individuals who are currently on diuretics or thyroid supplements
6. Individuals on lipid-lowering therapies.
7. Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
8. Individuals who are currently on antihypertensive medication.
9. Individuals with cardiac arrhythmia, impaired hepatic or renal function
10. Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
11. History of malignancy or stroke.
12. Chronic alcoholism: History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by i.For men consuming more than 4 drinks on any day or more than 14 drinks/week ii. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
13. Individuals taking concomitant medication known to alter blood sugar.
14. Individuals having treatment with herbal or any other supplements.
15. Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.
16. Use of another investigational product within 3 months of the screening visit.
17. Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active 1200 mg per soft gel capsule; Combination of Vitamin B1, B6, B12, D3, Chromium Picolinate, Proprietary Mulberry Leaf Extract, Cinnamon Bark Powder, Gymnema Sylvestre Extract, Insulina (Cissus Sicyoides) Leaf Extract, Alpha Lipoic Acid, Phellodendron Bark Extract (Berberine HCL), Cissus Quadrangularis Extract, Banaba Leaf Extract, & Fish Oil. Two soft gels to be taken with breakfast and two soft gels to be taken with dinner	Dietary supplement: IP 1200 mg per soft gel capsule; Two soft gels to be taken with breakfast and two soft gels to be taken with dinner
Placebo Comparator: Placebo (Soyabean oil) 1200 mg per soft gel capsule; Two soft gels to be taken with breakfast and two soft gels to be taken with dinner	Dietary supplement: Placebo Comparator: Placebo 1200 mg per soft gel capsule; Two soft gels to be taken with breakfast and two soft gels to be taken with dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2024
• Primary Completion (Estimated): December 25, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: NH/231201/GC/DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No