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

NCT06496893 | Not Yet Recruiting

• 1 other identifier: NH/231201/GC/DM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Pre Diabetes; Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  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

  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

  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

  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

  Day 0, Day 30, Day 60, Day 90

Study Arms (2)

Active 1200 mg per soft gel capsule

ACTIVE COMPARATOR

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

Placebo (Soyabean oil) 1200 mg per soft gel capsule

PLACEBO COMPARATOR

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

Interventions

IP 1200 mg per soft gel capsule DIETARY_SUPPLEMENT

Two soft gels to be taken with breakfast and two soft gels to be taken with dinner

Active 1200 mg per soft gel capsule

Placebo Comparator: Placebo 1200 mg per soft gel capsule DIETARY_SUPPLEMENT

Two soft gels to be taken with breakfast and two soft gels to be taken with dinner

Placebo (Soyabean oil) 1200 mg per soft gel capsule

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Individuals having non-vegetarian diet for at least 2 days a week.
• Non-smoker.
• Individuals who are willing to not change their physical activity levels throughout the study period.
• Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
• Individuals ready to give voluntary, written informed consent to participate in the study.

You may not qualify if:

• 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.
• Individuals who are currently on diuretics or thyroid supplements
• Individuals on lipid-lowering therapies.
• Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
• Individuals who are currently on antihypertensive medication.
• Individuals with cardiac arrhythmia, impaired hepatic or renal function
• Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
• History of malignancy or stroke.
• 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
• Individuals taking concomitant medication known to alter blood sugar.
• Individuals having treatment with herbal or any other supplements.
• Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

Shourya clinic

Pune, Maharashta, India

Location

Shri balaji Multispeciality hospital,

Thane, Maharashtra, 421503, India

Location

Dr.Govinds Clinic,

Jaipur, Rajashthan, 302033, India

Location

Upendra Medicare

Varanasi, Uttar Pradesh, 221001, India

Location

Arihant Hospital

Varanasi, Uttar Pradesh, 221011, India

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Dr. Shalini Srivastava,, MBBS, MD

CONTACT

7738418890; shalini.s@vediclifesciences.com

Lalit Pawaskar, M.Pharm, PGDM

CONTACT

7738418890; lalit.p@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 25, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)