Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy

Post Graduate Institute of Medical Education and Research, Chandigarh50 enrolled

Overview

The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.

The study assessed and estimated the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks. The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Pancreatic Lipomatosis

Interventions

Dapagliflozin 10mg TabDRUG

Dapagliflozin was given at a dose of 10 mg/day in one group and its effect was observed on the pancreatic fat content

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years, 2. Hba1c 7-11%, 3. Renal function (MDRD) \> 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, or basal insulin} at a stable dose for at least 3 months. Exclusion Criteria: 1. Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL). 2. Diabetes other than type 2 diabetes 3. Age younger than 18 years. 4. Pregnant patients or lactating. 5. Patients who refuse to give consent to be enrolled in the study. 6. Any contraindication to magnetic resonance imaging. 7. More than 5% total body weight loss within the last month. 8. Patients with moderate or severe renal impairment 9. Any contraindication to SGLT2i 10. Prior SGLT2i within the past 3 months

Locations (1)

Deptt of Endocrinology

Chandigarh, India

Outcomes

Primary Outcomes

To assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks

The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a change will be compared

Time frame: 24 weeks

Secondary Outcomes

To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)

The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a correlation will be assessed

Time frame: 24 weeks

Data from ClinicalTrials.gov

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