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

Phase 4

Completed

• Conditions: Pancreatic Lipomatosis
• Interventions: Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT05797935
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-31
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Status Verified: 2023-04
• Study First Posted: 2023-04-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin 10mg Tab	The patients were given standard drugs for type 2 diabetes and Dapagliflozin.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)	24 weeks	The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a correlation will be assessed

Trial Locations

Locations (1)

Deptt of Endocrinology; 🇮🇳 Chandigarh, India