Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01672255 · ClinicalTrials.gov registry record · Early Phase 1
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
A Early Phase 1 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 64
- Enrollment target
NCT01672255 is a Early Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 64 participants.
The verdict
NCT01672255, a Early Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo control
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2012-10 |
| Est. Completion | 2025-05 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01672255
The ClinicalTrials.gov registry entry for NCT01672255 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.
NCT01672255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01672255 about?
NCT01672255 is a clinical study titled "Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)". 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...
What is the current status of trial NCT01672255?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 64 participants. The study started on 2012-10. Estimated completion is 2025-05.
What interventions are being tested in trial NCT01672255?
The interventions under investigation include: Placebo control (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT01672255?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.