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Effect of metformin on mitochondrial health in patients with newly diagnosed Type 2 diabetes mellitus.

Status of mitophagy in subjects with prediabetes and type 2 diabetes and effect of metformin on mitophagy in newly detected patients with type 2 diabetes

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008422
Enrollment
45
Registered
2017-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: Metformin: Metformin Oral Administration 1000mg twice a day Control Intervention1: Placebo, Voglibose: Placebo Oral Administration 1000mg twice a day, Voglibose Oral Administration 0.3

Sponsors

Director PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.T2DM patients with BMI of more than 25 kg/m² 2.Duration of diabetes less than 6 months. 3. FPG of more than 126 mg/dl and 2hPG more than 200 mg /dl or RPG of more than 200 mg/dl with the presence of symptoms. 4.This will be complimented by HbA1c of more than 6.5%.

Exclusion criteria

Exclusion criteria: 1.Patients with type 1 diabetes mellitus, secondary diabetes or GAD 65 positive 2.Abnormal liver and renal function tests 3. History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months and malignancy 4.Patients on Glucocorticoids 5.Pregnancy

Design outcomes

Primary

MeasureTime frame
Achievement of the target of HbA1c levels less than 7 percent and expression profiling of mitophagy-related markersTimepoint: At Baseline and after 3 months (Post Metformin, Placebo and Voglibose treatment)

Secondary

MeasureTime frame
Change in weight, BMI,lipid profile , FPG, 2hPG, HbA1C and indices of glucose-insulin homeostasis.Timepoint: At Baseline and after 3 months (Post Metformin, Placebo and Voglibose treatment)

Countries

India

Contacts

Public ContactShipra Bhansali

Post Graduate Institute of Medical Education and Research

veenad2001@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026