Effect of tablet Targlut on blood sugar control

Not Applicable

Conditions: Health Condition 1: R730- Abnormal glucoseHealth Condition 2: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2023/02/049986

Lead Sponsor: Composite Interceptive Med Science Laboratories Pvt. Ltd,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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 <90 mL/min/1.73 m2)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Glycated hemoglobin (HbA1c) <br/ ><br>between the 2 groupsTimepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in blood sugar level FBS, PPBS <br/ ><br>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