Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT06333132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission", 'timeFrame': '12 weeks', 'description': 'The investigators will test whether diabetes remission obtained after 10% weight-loss, induced by an intensive nutritional intervention, is associated with an improvement of the incretin effect from baseline.\n\nDiabetes remission will be defined according to the latest international consensus as an HbA1c \\<48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy.\n\nThe restoration of the incretin effect will be assessed by measuring both incretin levels and estimated incretin mediated insulin secretion before and after achieving the weight loss during an Oral Glucose Tolerance Test followed by an intravenous Glucose Tolerance Test.'}], 'secondaryOutcomes': [{'measure': 'Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months', 'timeFrame': '36 weeks', 'description': 'Diabetes remission will be defined according to the latest international consensus as an HbA1c \\<48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy.\n\nThus, diabetes remission will be assessed after the end of the intervention phase (V1). Participants who will achieve diabetes remission at V1 will be monitored by measuring HbA1c for the next 6 months at 3-month intervals (V2 and V3).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Diabetes Mellitus Type 2 in Obese']}, 'descriptionModule': {'briefSummary': 'The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.', 'detailedDescription': 'Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:\n\n* measurement of fasting glucose and glycated hemoglobin\n* Indirect calorimetry\n* oral glucose tolerance test\n* intravenous glucose tolerance test\n* quality of life and diet-related questionnaires\n* 72-hour food records\n\nAt the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2D for less than 6 years;\n* age 18-65 years;\n* both genders;\n* BMI 27-45 kg/m2;\n* HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).\n\nExclusion Criteria:\n\n* type 1 or secondary/genetic diabetes;\n* treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;\n* weight loss \\>5% within the previous 6 months;\n* eGFR \\<30 ml/min/1.73m2;\n* myocardial infarction within the previous 6 months;\n* severe heart failure (NYHA III-IV); eating disorder; substance abuse;\n* severe depression;\n* known cancer;\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT06333132', 'acronym': 'DiabEATit', 'briefTitle': 'Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Pisana'}, 'officialTitle': 'Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DiabEAT.it'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese subjects with type 2 diabetes mellitus', 'description': 'Individualized weight-loss nutritional intervention', 'interventionNames': ['Behavioral: Weight loss-induced Diabetes Remission']}], 'interventions': [{'name': 'Weight loss-induced Diabetes Remission', 'type': 'BEHAVIORAL', 'description': 'Patients will undergo a dietary intervention plus drugs (if needed) with the purpose to obtain a 10% (or at least 10 kg) body weight reduction to achieve diabetes remission', 'armGroupLabels': ['Obese subjects with type 2 diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56127', 'city': 'Pisa', 'state': 'PI', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'centralContacts': [{'name': 'Domenico Tricò, MD, PhD', 'role': 'CONTACT', 'email': 'd.trico@unipi.it', 'phone': '050993640'}, {'name': 'Luca Sacchetta, MD', 'role': 'CONTACT', 'email': 'luca.sacchetta@spec-med.unipi.it', 'phone': '050993640'}], 'overallOfficials': [{'name': 'Domenico Tricò, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pisa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Natali', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Pisana'}}}}