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Fluoxetine + DHEA for Type 1 Diabetes
Study Summary
This trial is testing the effects of the Selective Serotonin Reuptake Inhibitor (SSRI) fluoxetine, an antidepressant often used to treat depression, and the hormone dehydroepiandrosterone (DHEA) on the body's ability to defend against low blood sugar (hypoglycemia). Approximately 64 individuals with type 1 diabetes will take part in this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have a history of severe mental health issues.You have important abnormal test results or physical exam findings.Your creatinine level is higher than 1.6 mg/dl.Your HbA1c level is less than 11.0%.Your body mass index is less than 40.I am unable or unwilling to follow the required birth control measures.I do not have complications from diabetes like eye or nerve problems.I do not have uncontrolled high blood pressure or a history of severe heart or brain blood vessel problems.If you have a depression score higher than 50, you cannot participate.I am not taking medications like beta blockers, antidepressants, or opioids.I am between 18 and 50 years old with type 1 diabetes.Your body mass index is less than 40.I do not have liver failure or jaundice.I am on blood thinners, have anemia, or a bleeding disorder.I do not have serious heart problems.I am unable to understand and give consent for my own treatment.I do not have complications from diabetes like eye or nerve problems.I have pneumonia.I am between 18 and 50 years old with type 1 diabetes.I have had a recent stroke or brain injury.Your blood tests show low red blood cell count, low or high white blood cell count, or liver function issues. You also test positive for HIV, Hepatitis B, or Hepatitis C.I have had a fever over 38 °C.Your HbA1c level is less than 11.0%.
- Group 1: Placebo 1
- Group 2: Placebo 2
- Group 3: Fluoxetine
- Group 4: DHEA
- Group 5: Fluoxetine and DHEA
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do individuals older than 45 years qualify for enrollment in this trial?
"This particular medical trial is seeking individuals between 18 and 50 years old. For those outside of this demographic, there are 157 clinical trials for minors and 190 studies available to participants over 65."
What medical applications does dehydroepiandrosterone have?
"DHEA is frequently utilized to address myoclonus, and it can also be beneficial in the treatment of unipolar depression, obsessive-compulsive disorder, and anorexia nervosa."
What are the requirements to partake in this trial?
"This clinical trial is recruiting 60 subjects aged between 18 and 50 who are currently living with diabetes or another autoimmune disorder. Additionally, applicants must satisfy the following criteria: 64 (32 male, 32 female) T1DM patients between ages of 18-50; HbA1c lower than 11%; no evidence of diabetic tissue complications such as retinopathy, neuropathy, stasis ulcers etc.; Body mass index below 40 kg/m2."
Are participants being sought for this experiment currently?
"In accordance with the clinicaltrials.gov listing, this experiment is recruiting participants. It was originally posted on December 19th 2017 and last modified on April 8th 2022."
How many individuals have the opportunity to participate in this medical trial?
"Affirmative. Clinicaltrials.gov data confirms that the trial, which was first publicized on December 19th 2017, is actively enrolling participants. The researchers are looking to welcome 60 patients from a single medical site."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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