Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05139420
Status:
SUSPENDED
Last Update Posted:
2025-01-31
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk of Metabolic Adaptation After Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'recruitment with pilot funding, which is competed', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in measured and predicted resting metabolic rate during and after weight loss', 'timeFrame': '18 months', 'description': 'resting metabolic rate will be measured by indirect calorimetry every 2 months for 6 months, then every 6 months for an additional 12 month. Predicted resting metabolic rate will be calculated with a mathematical formula at the same time points'}], 'secondaryOutcomes': [{'measure': 'change in circulating leptin during and after weight loss', 'timeFrame': '18 months', 'description': 'blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months'}, {'measure': 'change in circulating thyroid hormones during and after weight loss', 'timeFrame': '18 months', 'description': 'blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months'}, {'measure': 'change in circulating GLP-1 during and after weight loss', 'timeFrame': '18 months', 'description': 'blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months'}, {'measure': 'change in circulating PYY during and after weight loss', 'timeFrame': '18 months', 'description': 'blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months'}, {'measure': 'change in circulating AgRP during and after weight loss', 'timeFrame': '18 months', 'description': 'blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months'}, {'measure': 'change in 24h urine catecholamines during and after weight loss', 'timeFrame': '18 months', 'description': 'urine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months'}, {'measure': 'change in heart rate variability during and after weight loss', 'timeFrame': '18 months', 'description': 'blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resting metabolic rate', 'metabolic adaptation'], 'conditions': ['Weight Loss', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI \\> or = 30 any ethnicity\n\nExclusion Criteria:\n\nweight \\> or = 400 lbs.\n\ndiabetes (type 2 or type 1)\n\nhypertension\n\nheart disease\n\nkidney disease\n\nliver disease\n\nactive cancer\n\npost solid organ or bone marrow transplant\n\nHIV/AIDS\n\npregnancy\n\nbreastfeeding\n\ncurrent smoker\n\ncurrent recreational drug use'}, 'identificationModule': {'nctId': 'NCT05139420', 'briefTitle': 'Risk of Metabolic Adaptation After Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss', 'orgStudyIdInfo': {'id': 'PRO00039217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lifestyle intervention', 'description': 'Participants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching.', 'interventionNames': ['Other: lifestyle intervention with meal replacement program']}], 'interventions': [{'name': 'lifestyle intervention with meal replacement program', 'type': 'OTHER', 'description': 'participants will be enrolled in a medical weight loss program and will be given a 6 month subscription to a calorie-reduced meal replacement program, in addition to lifestyle advice.', 'armGroupLabels': ['lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Lisa L Morselli, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Lisa Morselli, MD PhD', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}