Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
NCT ID: NCT05797935
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2021-08-01
2022-12-31
Brief Summary
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Detailed Description
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The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Placebo group
Only the standard drugs for type 2 diabetes were given. Dapagliflozin was not given in this group.
No interventions assigned to this group
Dapagliflozin group
The patients were given standard drugs for type 2 diabetes and Dapagliflozin.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Ashu Rastogi
Associate professor, Department of endocrinology and metabolism , PGIMER chandigarh
Locations
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Deptt of Endocrinology
Chandigarh, , India
Countries
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Other Identifiers
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9805821254
Identifier Type: -
Identifier Source: org_study_id
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