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

• Sponsor: Postgraduate Institute of Medical Education and Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT05797935
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Lipomatosis	Drug: Dapagliflozin 10mg Tab	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised Control TrialRandomised Control Trial
• Masking: Single (Investigator)
• Masking Description: Single blind study
• Primary Purpose: Other
• Official Title: Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
• Actual Study Start Date: Aug 1, 2021
• Actual Primary Completion Date: Dec 20, 2022
• Actual Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deptt of Endocrinology	Chandigarh		India	160012

Sponsors and Collaborators

• Postgraduate Institute of Medical Education and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ashu Rastogi, Associate professor, Department of endocrinology and metabolism , PGIMER chandigarh, Postgraduate Institute of Medical Education and Research
• ClinicalTrials.gov Identifier: NCT05797935
• Other Study ID Numbers: 9805821254
• First Posted: Apr 4, 2023
• Last Update Posted: Apr 10, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ashu Rastogi, Associate professor, Department of endocrinology and metabolism , PGIMER chandigarh, Postgraduate Institute of Medical Education and Research: Dapagliflozin; Pancreatic fat; MRI; Diabetes; MRS
• Additional relevant MeSH terms: Lipomatosis; Dapagliflozin

Study Results

No Results Posted as of Apr 10, 2023