The Effects of Fluoxetine and/or DHEA
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ClinicalTrials.gov Identifier: NCT03228732 |
Recruitment Status :
Recruiting
First Posted : July 25, 2017
Last Update Posted : April 12, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Drug: Placebo Oral Tablet Drug: Fluoxetine Drug: DHEA Drug: Fluoxetine and DHEA | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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 |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | December 19, 2017 |
Estimated Primary Completion Date : | December 15, 2023 |
Estimated Study Completion Date : | December 15, 2024 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo 1
Visit 1: Study 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 Visit 2: same as visit 1 |
Drug: Placebo Oral Tablet
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits. |
Placebo Comparator: Placebo 2
Visit 1: Study 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 Visit 2: same as visit 1 |
Drug: Placebo Oral Tablet
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits. |
Active Comparator: Fluoxetine
Visit 1: Study 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 Visit 2: same as visit 1 |
Drug: Fluoxetine
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits. |
Active Comparator: DHEA
Visit 1: Study 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 Visit 2: same as visit 1 |
Drug: DHEA
There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
Other Name: dehydroepiandrosterone |
Active Comparator: Fluoxetine and DHEA
Visit 1: Study 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 Visit 2: same as visit 1 |
Drug: Fluoxetine and DHEA
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.
Other Name: Prozac, dehydroepiandrosterone |
- Change in the level of catecholamines in plasma [ Time Frame: An average of 3 years ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 64 (32 males, 32 females) T1DM patients aged 18-50 yr.
- HbA1c < 11.0%
- No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
- Body mass index < 40kg · m-2
Exclusion Criteria:
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- 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
- Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
- Subjects that score greater than 50 on the depression scale
- Subjects unwillingness or inability to comply with approved contraception measures
- Abnormal results following screening tests and physical examination that are clinically significant
- Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
- 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.
- Pneumonia
- Hepatic Failure/Jaundice
- Creatinine greater than 1.6 mg/dl
- Acute Cerebrovascular/ Neurological deficit
- Fever greater than 38 °C
Screening Laboratory Tests Exclusion Criteria
- Hematocrit lower than 32
- WBC lower than 3 thou/ul or greater than 14 thou/ul
- Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
- TBil greater than 2 mg/dl
- Alkaline Phosphatase greater than 150U/L
- Positive HIV, Hep B, Hep C
- Hepatic transaminase > 2x normal

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228732
Contact: Maka S Hedrington, MD | 410-706-5623 | mhedrington@som.umaryland.edu |
United States, Maryland | |
University of Maryland | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Maka S Hedrington, MD 410-706-5623 mhedrington@som.umaryland.edu |
Principal Investigator: | Stephen N Davis, MBBS | University of Maryland, Baltimore |
Responsible Party: | Stephen N. Davis, MBBS, Chairman of Medicine, University of Maryland, Baltimore |
ClinicalTrials.gov Identifier: | NCT03228732 |
Other Study ID Numbers: |
HP-00075896 |
First Posted: | July 25, 2017 Key Record Dates |
Last Update Posted: | April 12, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Fluoxetine Dehydroepiandrosterone Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors |