NCT01672255CompletedEarly phase 1
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise
Source: ClinicalTrials.gov · Last updated 6 Oct 2025
Brief summary (registry, in English)
Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS responses during exercise.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 17 Aug 2012
- Start date
- 1 Oct 2012
- Primary completion date
- 31 May 2025
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Type 1 diabetes
- NCT number
- NCT01672255
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 64
- From 1 Oct 2012 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Subjects with a recent medical illness
- Subjects with a history of hypertension, heart disease, cerebrovascular incidents
Other
- Pregnant women
- Subjects unable to give voluntary informed consent
- Current tobacco use
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland, Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.