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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2023
  • participants needed
    64
  • sponsor
    University of Maryland, Baltimore
Updated on 11 April 2021
diabetes
insulin
body mass index
neuropathy
hemoglobin a1c
glycosylated hemoglobin
retinopathy
hypoglycemia

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.

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetes Mellitus Types I and II, Hypoglycemia Associated Autonomic Failure, Diabetes (Pediatric), type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment Fluoxetine, Placebo control
Clinical Study IdentifierNCT01672255
SponsorUniversity of Maryland, Baltimore
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

(16 males, 16 females) Healthy controls aged 18-45 yr
(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
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