Clinical trial NCT03228732: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in the level of catecholamines in plasma
timeFrame: An average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Stephen N Davis, MBBS
role: PRINCIPAL_INVESTIGATOR
References: