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

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

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)

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

Conditions
-----------------
Pancreatic Lipomatosis

Intervention / Treatment
-----------------
* Drug: Dapagliflozin 10mg Tab


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Control Trial
Masking: Single


Arms and Interventions

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, MRS, Dapagliflozin, Pancreatic fat, Diabetes