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

April 6, 2023 updated by: Ashu Rastogi, Postgraduate Institute of Medical Education and Research
The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Deptt of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Placebo group
Only the standard drugs for type 2 diabetes were given. Dapagliflozin was not given in this group.
Active Comparator: Dapagliflozin group
The patients were given standard drugs for type 2 diabetes and Dapagliflozin.
Drug: Dapagliflozin 10mg Tab
Dapagliflozin was given at a dose of 10 mg/day in one group and its effect was observed on the pancreatic fat content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Estimate)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9805821254

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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