Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 2:27 PM
Study NCT ID:
NCT05766358
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role Of Metabolic Adaptation In Weight Regain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '12 months'}, {'measure': 'Body weight', 'timeFrame': '18 months'}, {'measure': 'Body fat mass (DXA)', 'timeFrame': '12 months'}, {'measure': 'Body fat mass (DXA)', 'timeFrame': '18 months'}, {'measure': 'Body fat mass (DXA)', 'timeFrame': '24 months'}, {'measure': 'Body fat free mass (DXA)', 'timeFrame': '12 months'}, {'measure': 'Body fat free mass (DXA)', 'timeFrame': '18 months'}, {'measure': 'Body fat free mass (DXA)', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss', 'Weight Gain', 'Obesity']}, 'descriptionModule': {'briefSummary': 'In a previous study (NCT04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. The participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. Before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-X-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. In this study, participants having provided their consent to be re-contacted will be invited to attend the research center 12,18 and 24 months after completing the lifestyle intervention. Body weight and composition will be measured, aiming to explore the association between metabolic adaptation and changes in body weight and composition after a weight loss intervention. In addition, we will explore whether weight and fat mass changes are different between groups, and whether these effects are mediated by metabolic adaptation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants having completed the NCT04081337 study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having participated in the study NCT04081337.\n\nExclusion Criteria:\n\n* Being pregnant.'}, 'identificationModule': {'nctId': 'NCT05766358', 'acronym': 'EXPEND-FU', 'briefTitle': 'Role Of Metabolic Adaptation In Weight Regain', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Role Of Metabolic Adaptation In Weight Regain: Expend Follow-Up', 'orgStudyIdInfo': {'id': 'PBRC 2022-027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placebo', 'interventionNames': ['Behavioral: Intensive lifestyle change therapy']}, {'label': 'Tirzepatide', 'interventionNames': ['Drug: Tirzepatide']}], 'interventions': [{'name': 'Intensive lifestyle change therapy', 'type': 'BEHAVIORAL', 'description': 'Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up', 'armGroupLabels': ['Placebo']}, {'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up', 'armGroupLabels': ['Tirzepatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Executive Director for Clinical Science', 'investigatorFullName': 'Eric Ravussin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}