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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01672255
• Other study ID #: HP-00044537; SSRI and Exercise
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 2012
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: Maka Siamashvili, MD
• Phone: 410-706-5623
• Email: msiamashvili[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fluoxetine
20 mg week 1, 40 mg week 2, 60 mg week 3, 80 mg week 4-6
• Placebo control
20 mg Week 1, 40 mg Week 2, 60 mg Week 3, 80 mg Week 4-6

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Catecholamines	This change in catecholamines will be compared to another 90 minute experimental period after 8 weeks administration of SSRI or placebo.	During 90 minute experimental period