Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 1:50 AM
Study NCT ID:
NCT03228732
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Fluoxetine and/or DHEA
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}, {'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into 2 groups. Group 1 will consist of a random order of Protocol 1 and Protocol 5. Group 2 will consist of a randomized order of Protocols 2, 3, 4'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the level of catecholamines in plasma', 'timeFrame': 'An average of 3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 64 (32 males, 32 females) T1DM patients aged 18-50 yr.\n* HbA1c \\< 11.0%\n* No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)\n* Body mass index \\< 40kg · m-2\n\nExclusion Criteria:\n\n* Pregnancy\n* Subjects unable to give voluntary informed consent\n* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses\n* Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens\n* Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease\n* Subjects that score greater than 50 on the depression scale\n* Subjects unwillingness or inability to comply with approved contraception measures\n* Abnormal results following screening tests and physical examination that are clinically significant\n* Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents\n* Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.\n* Pneumonia\n* Hepatic Failure/Jaundice\n* Creatinine greater than 1.6 mg/dl\n* Acute Cerebrovascular/ Neurological deficit\n* Fever greater than 38 °C\n\nScreening Laboratory Tests Exclusion Criteria\n\n* Hematocrit lower than 32\n* WBC lower than 3 thou/ul or greater than 14 thou/ul\n* Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).\n* TBil greater than 2 mg/dl\n* Alkaline Phosphatase greater than 150U/L\n* Positive HIV, Hep B, Hep C\n* Hepatic transaminase \\> 2x normal'}, 'identificationModule': {'nctId': 'NCT03228732', 'briefTitle': 'The Effects of Fluoxetine and/or DHEA', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'The Effects of the Selective Serotonin Reuptake Inhibitor, Fluoxetine and/or DHEA, on Neuroendocrine, Autonomic Nervous System and Metabolic Counterregulatory Responses During Repeated Hypoglycemia in T1DM Individuals', 'orgStudyIdInfo': {'id': 'HP-00075896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 1', 'description': 'Visit 1:\n\nStudy Day 1: Hyperinsulinemia/ euglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo\n\nVisit 2:\n\nsame as visit 1', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 2', 'description': 'Visit 1:\n\nStudy Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo\n\nVisit 2:\n\nsame as visit 1', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoxetine', 'description': 'Visit 1:\n\nStudy Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine\n\nVisit 2:\n\nsame as visit 1', 'interventionNames': ['Drug: Fluoxetine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DHEA', 'description': 'Visit 1:\n\nStudy Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with DHEA\n\nVisit 2:\n\nsame as visit 1', 'interventionNames': ['Drug: DHEA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoxetine and DHEA', 'description': 'Visit 1:\n\nStudy Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine and DHEA\n\nVisit 2:\n\nsame as visit 1', 'interventionNames': ['Drug: Fluoxetine and DHEA']}], 'interventions': [{'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.', 'armGroupLabels': ['Placebo 1']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.', 'armGroupLabels': ['Placebo 2']}, {'name': 'Fluoxetine', 'type': 'DRUG', 'description': 'There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.', 'armGroupLabels': ['Fluoxetine']}, {'name': 'DHEA', 'type': 'DRUG', 'otherNames': ['dehydroepiandrosterone'], 'description': 'There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.', 'armGroupLabels': ['DHEA']}, {'name': 'Fluoxetine and DHEA', 'type': 'DRUG', 'otherNames': ['Prozac, dehydroepiandrosterone'], 'description': 'There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.', 'armGroupLabels': ['Fluoxetine and DHEA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maka Siamashvili, MD', 'role': 'CONTACT', 'email': 'msiamashvili@som.umaryland.edu', 'phone': '410-706-5623'}], 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Maka Siamashvili, MD', 'role': 'CONTACT', 'email': 'msiamashvili@som.umaryland.edu', 'phone': '410-706-5623'}, {'name': 'Vanessa Briscoe, PhD', 'role': 'CONTACT', 'email': 'vbriscoe@som.umaryland.edu'}], 'overallOfficials': [{'name': 'Stephen N Davis, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Medicine', 'investigatorFullName': 'Stephen N. Davis, MBBS', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}