Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05797935
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2023-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single blind study'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Control Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-03-22', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '24 weeks', 'description': 'The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a change will be compared'}], 'secondaryOutcomes': [{'measure': 'To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)', 'timeFrame': '24 weeks', 'description': 'The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a correlation will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dapagliflozin', 'Pancreatic fat', 'MRI', 'Diabetes', 'MRS'], 'conditions': ['Pancreatic Lipomatosis']}, 'descriptionModule': {'briefSummary': 'The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.', 'detailedDescription': '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.\n\nThe investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years,\n2. Hba1c 7-11%,\n3. 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.\n\nExclusion Criteria:\n\n1. Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).\n2. Diabetes other than type 2 diabetes\n3. Age younger than 18 years.\n4. Pregnant patients or lactating.\n5. Patients who refuse to give consent to be enrolled in the study.\n6. Any contraindication to magnetic resonance imaging.\n7. More than 5% total body weight loss within the last month.\n8. Patients with moderate or severe renal impairment\n9. Any contraindication to SGLT2i\n10. Prior SGLT2i within the past 3 months'}, 'identificationModule': {'nctId': 'NCT05797935', 'briefTitle': 'Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy', 'orgStudyIdInfo': {'id': '9805821254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo group', 'description': 'Only the standard drugs for type 2 diabetes were given. Dapagliflozin was not given in this group.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin group', 'description': 'The patients were given standard drugs for type 2 diabetes and Dapagliflozin.', 'interventionNames': ['Drug: Dapagliflozin 10mg Tab']}], 'interventions': [{'name': 'Dapagliflozin 10mg Tab', 'type': 'DRUG', 'description': 'Dapagliflozin was given at a dose of 10 mg/day in one group and its effect was observed on the pancreatic fat content', 'armGroupLabels': ['Dapagliflozin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Deptt of Endocrinology', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Department of endocrinology and metabolism , PGIMER chandigarh', 'investigatorFullName': 'Ashu Rastogi', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}