Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT02830308
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2016-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Adults With Endocrine and Metabolic-Related Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003480', 'term': 'Cushing Syndrome'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09-17', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2016-07-09', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruit a diverse population of adult subjects with a known or suspected endocrine or metabolic disorder in order to provide NIDDK investigators and trainees with hands-on experience related to the diagnosis, management, treatment, and follow-up...', 'timeFrame': '12/31/2036', 'description': 'The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hormones', 'Endocrine', 'Hypercortisolism', 'Bone', 'Hypothalamic-Pituitary Dysfunction', 'Natural History'], 'conditions': ['Endocrine Diseases']}, 'referencesModule': {'references': [{'pmid': '39069898', 'type': 'DERIVED', 'citation': 'Abd-Elmoniem KZ, Edwan JH, Dietsche KB, Villalobos-Perez A, Shams N, Matta J, Baumgarten L, Qaddumi WN, Dixon SA, Chowdhury A, Stagliano M, Mabundo L, Wentzel A, Hadigan C, Gharib AM, Chung ST. Endothelial Dysfunction in Youth-Onset Type 2 Diabetes: A Clinical Translational Study. Circ Res. 2024 Aug 30;135(6):639-650. doi: 10.1161/CIRCRESAHA.124.324272. Epub 2024 Jul 29.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2016-DK-0125.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThere are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.\n\nObjectives:\n\nTo learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.\n\nEligibility:\n\nAdults age 18 years and older with a known or suspected endocrine disorder.\n\nRelatives ages 18 years and older.\n\nDoctors will review all requests and available medical records to determine final eligibility for the protocol.\n\nDesign:\n\nParticipants will have a medical history and physical exam.\n\nMost participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:\n\n* Blood, urine, and saliva tests\n* Imaging tests. These may include X-ray, ultrasound, or scans.\n* Sleep study\n* Medical photographs\n* Visits with other specialists at NIH\n\nParticipants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies.\n\nParticipants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.', 'detailedDescription': 'This is an observational protocol designed to collect data from adult subjects with known or suspected endocrine or metabolic disorders.\n\nOBJECTIVE: The overall purpose of endocrine evaluations under this protocol is to increase knowledge of endocrine or metabolic diseases. Adults with known or suspected endocrine or metabolic-related condition(s) may be evaluated under this protocol for:\n\n1. Collection of data for endocrine related conditions (case reports, case series)\n2. Collection of data for future research\n3. Collection of samples, including leftover samples from clinically indicated tests, for future research (including genomics)\n\nMETHODS: Patients will undergo a history and physical exam, anthropometrics, vital signs and endocrine laboratory studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Clinical', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Participants with known or suspected endocrine disorder age 18 years and older are eligible for this protocol. Protocol investigators will make the actual selection of subjects most appropriate for clinical evaluation.\n* Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.\n\nEXCLUSION CRITERIA:\n\n* Anyone under the age of 18 years old\n* Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. Subjects who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.'}, 'identificationModule': {'nctId': 'NCT02830308', 'briefTitle': 'Evaluation of Adults With Endocrine and Metabolic-Related Conditions', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Evaluation of Adults With Endocrine-Related Conditions', 'orgStudyIdInfo': {'id': '160125'}, 'secondaryIdInfos': [{'id': '16-DK-0125'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with known or suspected endocrine or metabolic dissorde', 'description': 'Adults with known or suspected endocrine or metabolic dissorders'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'prpl@cc.nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY8664111010'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Marissa F Lightbourne, M.D.', 'role': 'CONTACT', 'email': 'marissa.lightbourne@nih.gov', 'phone': '(301) 827-0033'}], 'overallOfficials': [{'name': 'Marissa F Lightbourne, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Not otherwise specified in protocol.', 'ipdSharing': 'YES', 'description': 'De-identified results from clinical trials will be posted on cctrials.gov', 'accessCriteria': 'Only investigators will have access to the data. Publications will not include subject names, nor will they contain personal identifying information. De-identified results from clinical trials will be posted on cctrials.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}