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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 4

Conditions: Pancreatic Lipomatosis

Treatments: Drug: Dapagliflozin 10mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05797935

9805821254

Details and patient eligibility

About

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

Full 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)

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Placebo group

No Intervention group

Description:

Only the standard drugs for type 2 diabetes were given. Dapagliflozin was not given in this group.

Dapagliflozin group

Active Comparator group

Description:

The patients were given standard drugs for type 2 diabetes and Dapagliflozin.

Treatment:

Drug: Dapagliflozin 10mg Tab