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

Launched by VEDIC LIFESCIENCES PVT. LTD. · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a product called Glucocil® to see how it affects metabolic health in people with prediabetes and Type 2 diabetes. The goal is to understand if Glucocil® can help improve conditions related to blood sugar levels and overall metabolic health. The study is set to start soon and is open to both men and women aged 30 to 70 who have specific health conditions related to prediabetes or newly diagnosed Type 2 diabetes.

To be eligible, participants should have a body mass index (BMI) between 30 and 35 and a larger waist measurement (over 40 inches for men and over 35 inches for women). Additionally, people with prediabetes must have certain blood sugar readings, while those with Type 2 diabetes should have mild to moderate levels of the condition. Participants will need to agree not to change their exercise routines during the trial and will complete questionnaires and attend study visits. It’s important to note that individuals on certain medications, those with specific health issues, or those who follow a strict vegetarian diet will not be able to participate. This study aims to gather valuable information about managing blood sugar levels and metabolic health.

Gender

ALL

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