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Completed

NCT Number: NCT05797935

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

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

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Key information

Conditions

Pancreatic Lipomatosis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Deptt of Endocrinology

Chandigarh, 160012, India

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Any contraindication to SGLT2i
  • Prior SGLT2i within the past 3 months

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

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

Primary outcomes

  1. 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

    Time frame: 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 outcomes

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

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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