Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Vanderbilt University
- Primary Endpoint
- catecholamines
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Day 1 hyperinsulinemic euglycemic clamps with either 0.2 mg fludrocortisone, 0.75 mg Dexamethasone, or both given orally before each morning and afternoon clamp. Day 2 hyperinsulinemic hypoglycemic glucose clamp.
Intervention: Fludrocortisone (Drug)
2
Fludrocortisone will be administered in doses of 0.05mg, 0.1mg and 0.2 mg form at the start of each clamp period on day 1. Dexamethasone will be administered orally in the doses of 0.18 mg, 0.375mg and 0.75mg doses. The combination of the 0.05mg fludrocortisone and 0.18mg dexamethasone and 0.1mg of fludrocortisone and 0.375 mg doses will be administered at the start of each day 1 clamp period. Day 2 90 minutes of moderate exercise.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
catecholamines
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Steve Davis
Department Chair
Vanderbilt University