CompletedPhase 4

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

India50 participantsStarted 2021-08-01

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years,
✓. Hba1c 7-11%,
✓. 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

✕. Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).
✕. Diabetes other than type 2 diabetes
✕. Age younger than 18 years.
✕. Pregnant patients or lactating.
✕. Patients who refuse to give consent to be enrolled in the study.
✕. Any contraindication to magnetic resonance imaging.
✕. More than 5% total body weight loss within the last month.
✕. Patients with moderate or severe renal impairment

What they're measuring

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

Timeframe: 24 weeks

Trial details

NCT IDNCT05797935

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-20

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