Clinical trial NCT06496893: A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.
Official title: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre Diabetes
Type2 Diabetes Mellitus
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled study
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Screening visit (The same value will be considered for baseline) and Day 90.
Secondary outcomes:
measure: 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
timeFrame: Screening visit (The same value will be considered for baseline) and Day 90.
measure: 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
timeFrame: Screening visit (The same value will be considered for baseline) and Day 90.
measure: 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
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Percentage change in body weight by weighing scale
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: 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
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in Fasting Blood Glucose (FBG)
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: 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
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: 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
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: To assess the effect of Investigational product (IP) on:Lipid profile [total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides]
timeFrame: Screening visit (The same value will be considered for baseline) and Day 90.
Other outcomes:
Locations:
city: Pune
country: India
facility: Shourya clinic
state: Maharashta
city: Thāne
country: India
facility: Shri balaji Multispeciality hospital,
state: Maharashtra
city: Jaipur
country: India
facility: Dr.Govinds Clinic,
state: Rajashthan
city: Varanasi
country: India
facility: Upendra Medicare
state: Uttar Pradesh
city: Varanasi
country: India
facility: Arihant Hospital
state: Uttar Pradesh
Study officials:
References: