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

This study is currently recruiting participants.
Verified March 2017 by Stephen N. Davis, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01672255
First Posted: August 24, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Hypoglycemia Associated Autonomic Failure Drug: Fluoxetine Drug: Placebo control Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise

Resource links provided by NLM:


Further study details as provided by Stephen N. Davis, University of Maryland:

Primary Outcome Measures:
  • Change in Catecholamines [ Time Frame: During 90 minute experimental period ]
    This change in catecholamines will be compared to another 90 minute experimental period after 8 weeks administration of SSRI or placebo.


Estimated Enrollment: 64
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trial 1-SSRI
90 minute exercise baseline with 6 weeks treatment with SSRI (Prozac). Repeat 90 minute exercise after 6 week treatment.
Drug: Fluoxetine
20 mg week 1, 40 mg week 2, 60 mg week 3, 80 mg week 4-6
Other Name: Prozac
Placebo Comparator: Trial 2-Placebo
90 minute exercise at baseline with 6 weeks treatment with placebo. Repeat 90 minute exercise after 6 weeks treatment of placebo.
Drug: Placebo control
20 mg Week 1, 40 mg Week 2, 60 mg Week 3, 80 mg Week 4-6

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672255


Contacts
Contact: Maka Hedrington, MD 410-706-5623 mhedrington@medicine.umaryland.edu
Contact: Donna Tate 410-706-5642

Locations
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Donna Tate    410-706-5643      
Principal Investigator: Stephen N. Davis, MBBS         
Sponsors and Collaborators
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stephen N. Davis, MBBS University of Maryland
  More Information

Responsible Party: Stephen N. Davis, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01672255     History of Changes
Other Study ID Numbers: HP-00044537; SSRI and Exercise
First Submitted: August 17, 2012
First Posted: August 24, 2012
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Stephen N. Davis, University of Maryland:
exercise
diabetes
SSRIs

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Pure Autonomic Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors


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