Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus, Type 1
Hypoglycemia
Hypoglycemia Associated Autonomic Failure
Pure Autonomic Failure
Type 1 Diabetes

Clinical Trial Details

NCT number	NCT01672255
Study type	Interventional
Source	University of Maryland, Baltimore
Contact	Maka Siamashvili, MD
Phone	410-706-5623
Email	msiamashvili@som.umaryland.edu
Status	Recruiting
Phase	Early Phase 1
Start date	October 2012
Completion date	December 2025

View Details

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