COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise

Quick Facts

Study Start:2012-10
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT01672255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 32 (16 males, 16 females) Healthy controls aged 18-45 yr.
  2. * 32 (16 males, 16 females) Type 1 diabetic patients aged 18-45 yr.
  3. * HbA1c 6-10.0%
  4. * Has been diagnosed Type 1 DM
  5. * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
  6. * Body mass index \< 40kg • m-2
  1. * Pregnant women
  2. * Subjects unable to give voluntary informed consent
  3. * Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
  4. * 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
  5. * Subjects with a recent medical illness
  6. * Subjects with a history of hypertension, heart disease, cerebrovascular incidents
  7. * Current tobacco use

Contacts and Locations

Principal Investigator

Stephen N. Davis, MBBS
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Stephen N. Davis, MBBS, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-10
Study Completion Date2025-05

Study Record Updates

Study Start Date2012-10
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • exercise
  • diabetes
  • SSRIs

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Hypoglycemia Associated Autonomic Failure