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
Trial tests if Prozac and/or DHEA help Type 1 diabetes patients manage low blood sugar.
Plain English Summary
The Effects of Fluoxetine and/or DHEA is a Phase 1 clinical trial sponsored by University of Maryland, Baltimore studying Type 1 Diabetes Mellitus. This study tests how fluoxetine (Prozac), DHEA, or both, affect the body's response to low blood sugar in people with Type 1 diabetes. It is for individuals aged 18-50 with Type 1 diabetes who have good blood sugar control and no diabetes-related organ damage. Participation involves two overnight stays in the hospital, with 8 weeks of taking study medication (Prozac, DHEA, both, or placebo) between visits. Alternative treatments for managing low blood sugar in Type 1 diabetes include careful blood sugar monitoring, adjusting insulin doses, and consuming fast-acting carbohydrates. The trial aims to enroll 60 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 50 years old, have Type 1 diabetes, and have an HbA1c below 11.0%. You cannot join if you are pregnant, have diabetes-related complications like eye or nerve damage, or have a history of severe mental health conditions. You also cannot join if you are taking certain medications, including beta-blockers, sedatives, or other antidepressants. Good general health is required, with no significant heart, liver, or kidney problems, and normal blood counts. This trial is studying Type 1 Diabetes Mellitus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how the study drugs change levels of certain stress hormones in the blood, which indicates how well the body is responding to low blood sugar. The specific primary outcome measures are: Change in the level of catecholamines in plasma (An average of 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a critical need to improve the body's natural defenses against dangerous low blood sugar episodes in people with Type 1 diabetes, a common and challenging complication. This research targets Type 1 Diabetes Mellitus, where improved treatment options are needed.
Investor Insight
This Phase 1 study explores novel therapeutic approaches for a common complication in a large patient population, potentially offering a new treatment avenue if successful. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about how fluoxetine and DHEA might affect your specific diabetes management plan and any potential interactions with your current medications. Be prepared for overnight hospital stays and the daily routine of taking study medication as prescribed. Understand that you will be monitored closely for any side effects or changes in your health during the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 60 participants
Interventions
- DRUG: Placebo Oral Tablet — There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
- DRUG: Placebo Oral Tablet — There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
- DRUG: Fluoxetine — There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
- DRUG: DHEA — There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
- DRUG: Fluoxetine and DHEA — There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.
Primary Outcomes
- Change in the level of catecholamines in plasma (An average of 3 years)
Full 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
Trial Locations
- University of Maryland, Baltimore, Maryland, United States
Frequently Asked Questions
What is clinical trial NCT03228732?
NCT03228732 is a Phase 1 INTERVENTIONAL study titled "The Effects of Fluoxetine and/or DHEA." It is currently recruiting and is sponsored by University of Maryland, Baltimore. The trial targets enrollment of 60 participants.
What conditions does NCT03228732 study?
This trial investigates treatments for Type 1 Diabetes Mellitus. The primary condition under study is Type 1 Diabetes Mellitus.
What treatments are being tested in NCT03228732?
The interventions being studied include: Placebo Oral Tablet (DRUG), Placebo Oral Tablet (DRUG), Fluoxetine (DRUG), DHEA (DRUG), Fluoxetine and DHEA (DRUG). There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
What does Phase 1 mean for NCT03228732?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT03228732?
This trial is currently "Recruiting." It started on 2017-12-19. The estimated completion date is 2026-12-15.
Who is sponsoring NCT03228732?
NCT03228732 is sponsored by University of Maryland, Baltimore. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03228732?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT03228732 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT03228732?
The primary outcome measures are: Change in the level of catecholamines in plasma (An average of 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03228732 being conducted?
This trial is being conducted at 1 site, including Baltimore, Maryland (United States).
Where can I find official information about NCT03228732?
The official record for NCT03228732 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03228732. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03228732 testing in simple terms?
This study tests how fluoxetine (Prozac), DHEA, or both, affect the body's response to low blood sugar in people with Type 1 diabetes. It is for individuals aged 18-50 with Type 1 diabetes who have good blood sugar control and no diabetes-related organ damage.
Why is this trial significant?
This trial addresses a critical need to improve the body's natural defenses against dangerous low blood sugar episodes in people with Type 1 diabetes, a common and challenging complication.
What are the potential risks of participating in NCT03228732?
Potential side effects of fluoxetine can include nausea, insomnia, and changes in mood. DHEA may cause side effects such as acne, hair loss, or voice changes. Both medications, when combined with diabetes, could potentially affect blood sugar control or increase the risk of mood changes. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03228732?
Ask your doctor about how fluoxetine and DHEA might affect your specific diabetes management plan and any potential interactions with your current medications. Be prepared for overnight hospital stays and the daily routine of taking study medication as prescribed. Understand that you will be monitored closely for any side effects or changes in your health during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03228732 signal from an investment perspective?
This Phase 1 study explores novel therapeutic approaches for a common complication in a large patient population, potentially offering a new treatment avenue if successful. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves two overnight stays in the hospital, with 8 weeks of taking study medication (Prozac, DHEA, both, or placebo) between visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Type 1 Diabetes Mellitus Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.