Understanding how exercise affects blood sugar in Type 1 diabetes
Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise
This study tests if giving fluoxetine can help people with Type 1 diabetes avoid low blood sugar during exercise compared to a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT01672255 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between exercise and hypoglycemia in individuals with Type 1 diabetes, focusing on the role of the autonomic nervous system (ANS) and serotonergic pathways. It aims to determine how exercise-induced hypoglycemia can be mitigated through the administration of fluoxetine compared to a placebo. The study includes healthy controls and Type 1 diabetic patients aged 18-45, assessing their ANS responses during exercise. By exploring these mechanisms, the research seeks to enhance exercise safety and adherence among diabetic patients.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals and Type 1 diabetic patients aged 18-45 with controlled HbA1c levels and no significant complications.
Not a fit: Patients with significant diabetic complications or those on certain medications that affect the autonomic nervous system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help Type 1 diabetes patients exercise more safely, reducing the risk of hypoglycemia.
How similar studies have performed: Other studies have shown promise in understanding the role of the autonomic nervous system in diabetes management, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 32 (16 males, 16 females) Healthy controls aged 18-45 yr. * 32 (16 males, 16 females) Type 1 diabetic patients aged 18-45 yr. * HbA1c 6-10.0% * Has been diagnosed Type 1 DM * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) * Body mass index \< 40kg • m-2 Exclusion Criteria: * Pregnant women * 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 * Subjects with a history of hypertension, heart disease, cerebrovascular incidents * Current tobacco use
Where this trial is running
Baltimore, Maryland
- University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Stephen N. Davis, MBBS — University of Maryland, Baltimore
- Study coordinator: Maka Siamashvili, MD
- Email: msiamashvili@som.umaryland.edu
- Phone: 410-706-5623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.