Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-09 @ 10:34 AM
Study NCT ID:
NCT02711059
Status:
WITHDRAWN
Last Update Posted:
2020-09-09
First Post:
2015-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Resistance in Primary Hyperparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006934', 'term': 'Hypercalcemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016105', 'term': 'Parathyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'studien skjuts på framtiden', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-06', 'studyFirstSubmitDate': '2015-10-18', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose tolerance test with estimation of insulin resistance', 'timeFrame': '3 months', 'description': 'Homa IR'}, {'measure': 'quality of life - self estimation protocol', 'timeFrame': '3 months', 'description': 'EORTC QLQ-C30'}], 'secondaryOutcomes': [{'measure': 'psychological wellbeing', 'timeFrame': '3 months', 'description': 'POMS'}, {'measure': 'anxiety, depression', 'timeFrame': '6 months', 'description': 'HAD'}, {'measure': 'cognition', 'timeFrame': '6 months', 'description': 'MoCA-Test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperparathyroidism', 'insulin resistance'], 'conditions': ['Hyperparathyroidism', 'Diabetes', 'Hypercalcemia']}, 'referencesModule': {'references': [{'pmid': '24026893', 'type': 'BACKGROUND', 'citation': 'Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.'}], 'seeAlsoLinks': [{'url': 'http://www.viss.nu/Handlaggning/Vardprogram/Endokrina-organ/Prediabetes/', 'label': 'Regional program'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.', 'detailedDescription': 'To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos \\>6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.\n\nThe test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary hyperparathyroidism and fb-glukos\\>6,1 and/or HbA1c \\> 39 mmol/mol\n\nExclusion Criteria:\n\n* Treatment with insulin, sulfonylurea or metformin'}, 'identificationModule': {'nctId': 'NCT02711059', 'acronym': 'IRIPH', 'briefTitle': 'Insulin Resistance in Primary Hyperparathyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation', 'orgStudyIdInfo': {'id': 'KarolinskaUH_pHPT_diabetes'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'parathyroidectomy', 'description': 'change in insulin resistance', 'interventionNames': ['Procedure: parathyroidectomy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'the study participant will be examined parallel with the active comparator'}], 'interventions': [{'name': 'parathyroidectomy', 'type': 'PROCEDURE', 'otherNames': ['parathyroid adenomectomy'], 'description': 'surgical treatment of hyperparathyroidism', 'armGroupLabels': ['parathyroidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Inga-Lena Nilsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, consultant surgeon', 'investigatorFullName': 'Inga-Lena Nilsson', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}