Status:
NOT_YET_RECRUITING
A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Pre Diabetes
Type2 Diabetes Mellitus
Eligibility:
All Genders
30-70 years
Phase:
NA
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
- 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.
Exclusion
- 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.
- Use of another investigational product within 3 months of the screening visit.
- Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06496893
Start Date
July 25 2024
End Date
December 30 2024
Last Update
July 11 2024
Active Locations (5)
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1
Shourya clinic
Pune, Maharashta, India
2
Shri balaji Multispeciality hospital,
Thane, Maharashtra, India, 421503
3
Dr.Govinds Clinic,
Jaipur, Rajashthan, India, 302033
4
Upendra Medicare
Varanasi, Uttar Pradesh, India, 221001