Clinical Trial

Autonomic Failure in Type 1 Diabetes Mellitus

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Fluoxetine

20 mg week 1, 40 mg week 2, 60 mg week 3, 80 mg week 4-6

Drug - Placebo control

20 mg Week 1, 40 mg Week 2, 60 mg Week 3, 80 mg Week 4-6

Additional Information

Official Study Title

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

Clinical Trial ID

NCT01672255

ParticipAid ID

QdJ8Da