Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 1:34 PM
Study NCT ID:
NCT03919656
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Dapagliflozin 10 mg, Green, plain, diamond shaped, film coated tablet (orally); Matching placebo for dapagliflozin Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1 ratio'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolomics changes in blood', 'timeFrame': 'From baseline to week 12', 'description': 'Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines'}, {'measure': 'Metabolomics changes in urine', 'timeFrame': 'From baseline to week 12', 'description': 'Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines'}], 'secondaryOutcomes': [{'measure': 'BMI (body mass index) changes', 'timeFrame': 'From baseline to to week 12', 'description': 'Measured by body composition analysis'}, {'measure': 'Changes in insulin resistance', 'timeFrame': 'From baseline to to week 12', 'description': 'Measured as HOMA-IR (homeostatic model assessment of insulin resistance)'}, {'measure': 'Changes in metabolic control', 'timeFrame': 'From baseline to to week 12', 'description': 'Measured as HbA1c (glycated hemoglobin)'}, {'measure': 'Changes in Quality of Life: 36-Item Short Form Health Survey (SF-36) questionnaire', 'timeFrame': 'From baseline to to week 12', 'description': 'The SF-36 has eight scaled scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The scores are weighted sums of the questions in each section. Scores range from 0 - 100, lower scores indicate more disability, and higher scores indicate less disability'}, {'measure': 'Changes in albuminuria', 'timeFrame': 'From baseline to to week 12', 'description': 'Modifications in albuminuria, measured as albumin excretion rate (AER)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolomics', 'Dapagliflozin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.', 'detailedDescription': "In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM.\n\nThe participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-75.\n* BMI 27-39.9 kg/m2.\n* T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).\n\nExclusion Criteria:\n\n* Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)\n* Breastfeeding\n* Intolerance/allergy to dapagliflozin.\n* Treatment with antidiabetic drug other than metformin.\n* Impaired kidney function: Estimated glomerular filtration rate (eGFR) \\<60 ml/min/1.73m2 (calculated using the CKD-EPI formula).\n* Patients with established cardiovascular disease.\n* Previous or current history of cancer of any kind.\n* Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).\n* History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels\\> 2.0 mg / dl or GOT/GPT levels three times higher than normal upper limit.\n* Known HIV infection or active HBV or HCV infection.\n* Other serious underlying diseases, which could affect the patient's ability to participate in the study.\n* Reduced life expectancy (\\<12 months) due to advanced or terminal concomitant diseases.\n\nIn addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice."}, 'identificationModule': {'nctId': 'NCT03919656', 'briefTitle': 'SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': 'SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection', 'orgStudyIdInfo': {'id': 'FIM-DAPA-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg daily (orally)', 'interventionNames': ['Drug: Dapagliflozin 10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo for dapagliflozin daily (orally). Does not contain active ingredient', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Dapagliflozin 10 mg', 'type': 'DRUG', 'otherNames': ['Farxiga 10 mg'], 'description': 'Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29010', 'city': 'Málaga', 'state': 'Spain', 'country': 'Spain', 'facility': 'Virgen de la Victoria University Hospital. Endocrinology Department', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Jose Carlos Fernandez-Garcia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virgen de la Victoria Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}