Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT01170832
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2010-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'We will collect approximately 15 ml of whole blood for DNA sampling and storage.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate (HR) Variability Studies', 'timeFrame': 'Three years', 'description': 'Evaluation of heart rate variability and 24 hour blood pressure monitoring: electrocardiogram (ECG) and blood pressure will be recorded while resting in a lying down position and during certain controlled procedures that include deep breathing and other clinical maneuvers such as standing up and exhaling deeply.'}], 'secondaryOutcomes': [{'measure': 'Positron Emission Tomography (PET) scan', 'timeFrame': 'Test to be completed at baseline and end of study (3yrs)', 'description': 'Subjects will have a heart positron emission tomography (PET) scan, using a radioisotope called \\[11C\\] hydroxyl-ephedrine (HED). This type of heart PET scan allows mapping the heart nerves. You will also have another scan with a radioisotope called \\[11C\\]-acetate which will help us measure the metabolism of your heart and how efficiently it contracts.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to impaired heart contractile (pumping) function and heart failure. It will also evaluate the natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes in the current standard of diabetes care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 diabetics who have been diagnosed between 5-10 years and do not have any complications that are associated with Diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion/Exclusion Criteria:\n\n* Male or female between the ages 18-65, with type 1 diabetes of 5-10 years duration who are free of complications and age-and-sex-matched healthy control volunteers.\n* Hemoglobin A1c greater than 7 %. (For Type 1 diabetics)\n* If you are a woman of childbearing potential you must agree to use an acceptable birth control method throughout the duration of the study. The methods of birth control that you can use are: Oral contraceptives (birth control pill), IUD or a barrier method (e.g. diaphragm or condom with spermicide).\n* You should have no history of any cardiovascular disease including any form of coronary artery disease, congestive heart failure, known arrhythmias (irregular heart beats), valvular disease or high blood pressure.\n* If you have any pacemaker or ICD, if you have any metallic foreign body such as surgical implants or clips or foreign bodies in the eye or orbits, wearing medication patches containing foil, or any other metal in the body or if you are claustrophobic you cannot participate in this study.\n* You should be free of any diabetic complications (e.g. nephropathy or kidney damage, retinopathy or eye damage), have no history of previous kidney, pancreas or cardiac transplantation, any other severe chronic illness that has neuropathy (numbness, burning or tingling) and/or neurologic disease as a recognized complication (e.g. Parkinson's disease, epilepsy), or any other serious medical conditions that may shorten life span (e.g. disabling stroke, Chronic Obstructive Pulmonary Disease).\n* You should be free of any malignancy other than basal cell skin cancer.\n* No history of alcohol abuse.\n* You should not use any agents or drugs that interfere with the imaging techniques described below.\n* You must be able to cooperate with the test protocols that are described below and be willing to sign this consent form.\n\nInclusion for Control group:\n\n* BMI \\<30\n* If female, must not be pregnant or nursing\n* Normal blood pressure\n* Normal labs-(glucose and lipids)"}, 'identificationModule': {'nctId': 'NCT01170832', 'briefTitle': 'To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'HUM 00036408'}}, 'contactsLocationsModule': {'locations': [{'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University Of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Rodica Pop-Busui, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine/MEND', 'investigatorFullName': 'Rodica Pop-Busui', 'investigatorAffiliation': 'University of Michigan'}}}}