Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Active (Combination of Vitamin B1, B6, B12, D3, Chromium Picolinate, Proprietary Mulberry Leaf Extract, Cinnamon Bark Powder, Gymnema Sylvestre Extract, Insulina (Cissus Sicyoides) Leaf
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion 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
Exclusion criteria: 1. Individuals who are vegetarians 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 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 (Greater than equal to 140/90mmHg) 8. Individuals 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 a) For men, consuming more than 4 drinks on any day or more than 14 drinks/week b) 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 any other 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.
Design outcomes
Primary
| Measure | 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).Timepoint: Screening visit (The same value will be considered for baseline) and Day 90 | — |
Secondary
| Measure | 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 (OGTT)Timepoint: 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 HbA1cTimepoint: Screening visit (The same value will be considered for baseline) and Day 90.;Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of IP on following compared to baseline and placebo: 1.Pancreatic efficiency as assessed by the change in the fasting insulin 2. Percentage change in body weight by weighing scale 3.Change in central obesity as assessed by the change in the anthropometric index of waist-to-height ratio 4. Change in the Fasting Blood Glucose (FBG) 5. Change in Quality of life as assessed by SF- 6Dv2TM Health Survey 6.Change in the Eating behavior as assessed by Three factor eating questionnaire â?? Revised 18 (TFEQ-R18)Timepoint: 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] Timepoint: Screening visit (The same value will be considered for baseline) and Day 90. | — |
Countries
India
Contacts
Public ContactLalit Pawaskar
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed