Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|
|
Type 1 Diabetes Hypoglycemia Associated Autonomic Failure |
Drug: Fluoxetine Drug: Placebo control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise |
- Change in Catecholamines [ Time Frame: During 90 minute experimental period ] [ Designated as safety issue: No ]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: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Maka Hedrington, MD | 410-706-5623 | mhedrington@medicine.umaryland.edu |
| Contact: Donna Tate | 410-706-5642 |
| 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 | |
| Principal Investigator: | Stephen N. Davis, MBBS | University of Maryland, Baltimore County |
More Information
No publications provided
| Responsible Party: | Stephen N. Davis, Principal Investigator, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01672255 History of Changes |
| Other Study ID Numbers: | SSRI and Exercise |
| Study First Received: | August 17, 2012 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Maryland:
|
exercise diabetes SSRIs |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Hypoglycemia Pure Autonomic Failure 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 Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013