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The Effects of Fluoxetine and/or DHEA

Primary Purpose

Type 1 Diabetes Mellitus

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo Oral Tablet
Placebo Oral Tablet
Fluoxetine
DHEA
Fluoxetine and DHEA
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MarylandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo 1

Placebo 2

Fluoxetine

DHEA

Fluoxetine and DHEA

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Change in the level of catecholamines in plasma

Secondary Outcome Measures

Full Information

First Posted
July 20, 2017
Last Updated
February 10, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03228732
Brief Title
The Effects of Fluoxetine and/or DHEA
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Placebo 2
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Fluoxetine
Arm Type
Active Comparator
Arm Description
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
Arm Title
DHEA
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fluoxetine and DHEA
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
dehydroepiandrosterone
Intervention Description
There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine and DHEA
Other Intervention Name(s)
Prozac, dehydroepiandrosterone
Intervention Description
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.
Primary Outcome Measure Information:
Title
Change in the level of catecholamines in plasma
Time Frame
An average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maka Siamashvili, MD
Phone
410-706-5623
Email
msiamashvili@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Briscoe, PhD
Email
vbriscoe@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen N Davis, MBBS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maka Siamashvili, MD
Phone
410-706-5623
Email
msiamashvili@som.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Fluoxetine and/or DHEA

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