Pancreatic Lipomatosis
Conditions
Keywords
Dapagliflozin, Pancreatic fat, MRI, Diabetes, MRS
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)
Interventions
DRUGDapagliflozin 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
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Single blind study
Intervention model description
Randomised Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Outcome results
None listed