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

NCT05797935 | Completed Phase 4

• 1 other identifier: 9805821254
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Lipomatosis

Keywords

Dapagliflozin; Pancreatic fat; MRI; Diabetes; MRS

Outcome Measures

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

  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 Outcomes (1)

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

  24 weeks

Study Arms (2)

Placebo group

NO INTERVENTION

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

Dapagliflozin group

ACTIVE COMPARATOR

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

Drug: Dapagliflozin 10mg Tab

Interventions

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

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Deptt of Endocrinology

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of endocrinology and metabolism , PGIMER chandigarh

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: August 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 31, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

IN (1)