Effects of Metformin Therapy on Pancreatic and Hepatic Fat Content in Patients of Type 2 Diabetes Mellitus

NCT05939921 | Completed

• 1 other identifier: MET
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A sample size of 15 patients with T2DM visiting Fortis C DOC Hospital will be recruited with informed, written consent and will be requested to answer a validated questionnaire in a language known to them (English/Hindi). All these patients will undergo 2 weeks diet and exercise run in period using standard guidelines. Clinical details will be obtained from the case records of the patients. Anthropometry, skinfolds \& blood pressure will be recorded as mentioned in previous studies from our group (see below for details)18,19. Overweight and, obesity will be defined according to predefined guidelines for Asian Indians20. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females21. Each eligible subject will undergo ultrasonography of liver and pancreas before recruitment. Following ultrasonography, patients fulfilling the inclusion will be randomised to receive the 10 mg of Dapagliflozin as mentioned previously. Biochemistry, ultrasonography, DEXA, MRI, will be performed at baseline and at 4 months post intervention.

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

• To assess the effect of metformin on Pancreatic fat and hepatic fat in T2DM patients.

  T2DM patients will undergo MRI, Ultrasound and Fibroscan testing to determine the level of fat in pancreas and liver.

  120 days

Study Arms (1)

Treatment

EXPERIMENTAL

T2DM patients will be provided with metformin in a specified dose

Drug: Metformin

Interventions

Metformin DRUG

T2DM patients will be provided with metformin in a specified dose

Treatment

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight \& obese (BMI 23.0 -35 kg/m2) subjects aged 30-60 years with T2DM of less than 5 year duration with HbA1c 6.5% to 9% \& on a stable dose of metformin and/or sulphonylureas over last 8 weeks, fatty liver on ultrasound.

You may not qualify if:

• The sample patient excluded in this study who had following medical history like: hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes, severe cardiac and renal disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant ,substantial alcohol consumption, Child-Pugh B/C cirrhosis, other causes of liver disease, confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E), and disorders such as a medical history of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) ,type 1 diabetes mellitus.

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• National Diabetes Obesity and Cholesterol Foundation: collaborator

Study Sites (1)

Anoop misra

New Delhi, National Capital Territory of Delhi, 110048, India

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Anoop Misra, MD

  Fortis CDOC Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: May 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)