Health Condition 1: R730- Abnormal glucose Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Tablet Targlut: Each tablet 600 mg to be taken twice a day before food along with standard of care for 3 months
Control Intervention1: Placebo: To be taken twice a day before food along
Sponsors
Composite Interceptive Med Science Laboratories Pvt. Ltd,
Eligibility
Inclusion criteria
Inclusion criteria: Adults of age 30 years and above (either gender) with a diagnosis of prediabetes or diabetes mellitus (on stable dose for 3 months) satisfying one or more of the American Diabetes Association (ADA) criteria and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with HbA1c > 10 or blood sugar level > 300 mg/dl 2. Current use of insulin (if administered previously, there should be a gap of at least 3 months) 3. History of stroke. MI or any revascularization procedure within the last 3 months 4. NYHA class III or IV 5. Pregnant and lactating women or planning to become pregnant in the next 12 weeks 6. Current daily use of any supplement containing the herbs in the study supplement 7. Patients with history of thyroid disorder or any other endocrine disorder that can affect blood sugar level or patient participation 8. Drugs that can increase blood sugar level such as corticosteroids 9. Impaired renal function (eGFR 10. Abnormal liver enzymes (more than 2 times the upper limit of normal) 11. Patients diagnosed with malignancy 12. Patients with diagnosis of psychiatric illness or addiction 13. Patients with history of autoimmune disease or immune compromising disease including HIV/AIDS 14. Any other condition which on the opinion of the study investigator makes the patient ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycated hemoglobin (HbA1c) between the 2 groupsTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood sugar level FBS, PPBS Timepoint: Baseline, 4 weeks, 12 weeks;Change in cardiac parameters (blood pressure, lipid profile)Timepoint: Baseline, 4 weeks and 12 weeks;Change in Diabetes distress scaleTimepoint: Baseline, 12 weeks;Change in inflammatory markersTimepoint: Baseline, 4 weeks and 12 weeks;Compliance and safety of TarglutTimepoint: 12 weeks;Effect of genetic polymorphism on treatment responseTimepoint: Baseline;Effect on metabolic parameters (Insulin resistance, Beta cell function and weight gain)Timepoint: Baseline, 4 weeks and 12 weeks;Glycemic variability using continuous glucose monitoring (sub group)Timepoint: Baseline, 12 weeks | — |
Countries
India
Contacts
Public ContactDr VikneswaranG
Narayana Institute of cardiac sciences
Outcome results
None listed