RECRUITING

The Effects of Fluoxetine And/or DHEA

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Conditions

Type 1 Diabetes Mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

(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.

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

Quick Facts

Study Start:2017-12-19
Study Completion:2026-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03228732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 64 (32 males, 32 females) T1DM patients aged 18-50 yr.
  2. * HbA1c \< 11.0%
  3. * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
  4. * Body mass index \< 40kg · m-2
  1. * Pregnancy
  2. * Subjects unable to give voluntary informed consent
  3. * Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
  4. * 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
  5. * Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
  6. * Subjects that score greater than 50 on the depression scale
  7. * Subjects unwillingness or inability to comply with approved contraception measures
  8. * Abnormal results following screening tests and physical examination that are clinically significant
  9. * Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
  10. * 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.
  11. * Pneumonia
  12. * Hepatic Failure/Jaundice
  13. * Creatinine greater than 1.6 mg/dl
  14. * Acute Cerebrovascular/ Neurological deficit
  15. * Fever greater than 38 °C
  16. * Hematocrit lower than 32
  17. * WBC lower than 3 thou/ul or greater than 14 thou/ul
  18. * Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
  19. * TBil greater than 2 mg/dl
  20. * Alkaline Phosphatase greater than 150U/L
  21. * Positive HIV, Hep B, Hep C
  22. * Hepatic transaminase \> 2x normal

Contacts and Locations

Study Contact

Maka Siamashvili, MD
CONTACT
410-706-5623
msiamashvili@som.umaryland.edu
Vanessa Briscoe, PhD
CONTACT
vbriscoe@som.umaryland.edu

Principal Investigator

Stephen N Davis, MBBS
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

University of Maryland
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Stephen N Davis, MBBS, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-19
Study Completion Date2026-12-15

Study Record Updates

Study Start Date2017-12-19
Study Completion Date2026-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes Mellitus