Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT03458533
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D015390', 'term': 'Gastric Bypass'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-04', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pituitary volume', 'timeFrame': '0, +3 years', 'description': 'Change in pituitary volume (mm3) from baseline to 3 years'}], 'secondaryOutcomes': [{'measure': 'Evaluation of pituitary mean and standard deviation intensity', 'timeFrame': '0, +3 years', 'description': 'Changes in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years'}, {'measure': 'Correlation of magnetic resonance parameters with anthropometric measurements', 'timeFrame': '0, +3 years', 'description': 'Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements'}, {'measure': 'Correlation of magnetic resonance parameters with pituitary axis function', 'timeFrame': '0, +3 years', 'description': 'Correlation analysis of pituitary mean and standard deviation intensity with pituitary axis function'}, {'measure': 'Correlation of magnetic resonance parameters with glyco-metabolic status', 'timeFrame': '0, +3 years', 'description': 'Correlation analysis of pituitary mean and standard deviation intensity with glyco-metabolic status'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pituitary', 'Obesity', 'Overweight', 'Metabolic syndrome', 'MRI'], 'conditions': ['Overweight and Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '37479795', 'type': 'DERIVED', 'citation': 'Puliani G, Sbardella E, Cozzolino A, Sada V, Tozzi R, Andreoli C, Fiorelli M, Di Biasi C, Corallino D, Balla A, Paganini AM, Venneri MA, Lenzi A, Lubrano C, Isidori AM. Pituitary T1 signal intensity at magnetic resonance imaging is reduced in patients with obesity: results from the CHIASM study. Int J Obes (Lond). 2023 Oct;47(10):948-955. doi: 10.1038/s41366-023-01338-w. Epub 2023 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to identify new morphological and quantitative magnetic imaging parameters of pituitary gland and sellar region in overweight and obese patient at baseline and after 3 years, dividing patients in 3 groups (weight loss through diet and lifestyle changes, weight loss through bariatric surgery, no weight loss)', 'detailedDescription': 'This longitudinal prospective study in overweight and obese patients aims to identify and characterize new morphological and quantitative MRI parameters of pituitary gland and sellar region assessed by texture analysis with a specific software (ImageJ©). These parameters will be correlated them to hypothalamic-pituitary-peripheral axis function, metabolism and body composition.\n\nData will be detected at baseline and at 3 years follow-up to quantitatively identify the different pituitary MRI patterns in 3 groups:\n\n1. patients without weight modifies\n2. patients with weight loss obtain through diet and lifestyle changes\n3. patients with weight loss obtained through bariatric surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overweight and obese patients come to our attention for weight loss interventions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 25 Kg/m2\n\nExclusion Criteria:\n\n* Malignant neoplasia;\n* Current use of psychotropic drugs;\n* Chronic renal failure;\n* Pituitary macroadenomas and craniopharyngiomas;\n* Contraindications to MRI execution (p. e. pace-maker, metal foreign bodies like slivers, non MRI compatible vascular clips or prosthesis)'}, 'identificationModule': {'nctId': 'NCT03458533', 'acronym': 'CHIASM', 'briefTitle': 'Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Changes in the Hypothalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity', 'orgStudyIdInfo': {'id': '4249'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Obese patients with indication to bariatric surgery', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'Group 2', 'description': 'Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes', 'interventionNames': ['Behavioral: Diet and lifestyle changes']}, {'label': 'Group 3', 'description': 'Overweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes', 'interventionNames': ['Behavioral: Diet and lifestyle changes']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'otherNames': ['sleeve gastrectomy', 'gastric bypass', 'bilio-intestinal bypass'], 'armGroupLabels': ['Group 1']}, {'name': 'Diet and lifestyle changes', 'type': 'BEHAVIORAL', 'otherNames': ['hypocaloric diet', 'physical exercise'], 'armGroupLabels': ['Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Andrea M Isidori', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Andrea M Isidori, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Andrea M. Isidori', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}