Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Vanderbilt University

Overview

The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Conditions

Type 1 Diabetes

Interventions

FludrocortisoneDRUG

Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1

DexamethasoneDRUG

Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 16 (8 males, 8 females) Type 1 diabetic patients aged 18-45 yr. * HbA1c \> 7.0% * Had diabetes for 2-15 years * No clinical evidence of diabetic tissue complications * 16 (8 males, 8 females) Healthy volunteers aged 18-45 yrs. * Body mass index \< 27kg · m-2 Exclusion Criteria: * Prior or current history of poor health * Abnormal results following blood and physical examination * Pregnancy

Outcomes

Primary Outcomes

catecholamines

Time frame: 1 year

Data from ClinicalTrials.gov

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