Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT00870259
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Physiological Adaptations to Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline', 'timeFrame': '2, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state', 'timeFrame': 'week 8 vs week 10'}, {'measure': 'Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety', 'timeFrame': '0, 2, 6 and 12 months'}, {'measure': 'Association of psychosocial factors with successful weight maintenance', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight loss', 'Weight maintenance'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '22029981', 'type': 'DERIVED', 'citation': 'Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and post-menopausal females\n* aged over 18 years\n* BMI 27-40kg/m2\n* weight-stable\n\nExclusion Criteria:\n\n* major comorbid medial condition (including diabetes)\n* taking medications known to affect weight\n* smoking'}, 'identificationModule': {'nctId': 'NCT00870259', 'briefTitle': 'Investigating Physiological Adaptations to Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'officialTitle': 'An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss', 'orgStudyIdInfo': {'id': 'HP 508920'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Optifast VLCD', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Meal replacement, three times daily for 8 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3081', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Heidelberg Repatriation Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical research fellow', 'investigatorFullName': 'Priya Sumithran', 'investigatorAffiliation': 'University of Melbourne'}}}}