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Trial record 69 of 236 for:    PRASTERONE

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 : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen N. Davis, MBBS, University of Maryland, Baltimore

Brief Summary:
(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.

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

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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 10, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Fluoxetine

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




Primary Outcome Measures :
  1. Change in the level of catecholamines in plasma [ Time Frame: An average of 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Maka S Hedrington, MD 410-706-5623 mhedrington@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Maka S Hedrington, MD    410-706-5623    mhedrington@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Stephen N Davis, MBBS University of Maryland, Baltimore

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Responsible Party: Stephen N. Davis, MBBS, Chairman of Medicine, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03228732     History of Changes
Other Study ID Numbers: HP-00075896
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Fluoxetine
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