Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Not Applicable

Withdrawn

• Conditions: Type 1 Diabetes
• Interventions: Drug: Fludrocortisone; Drug: Dexamethasone

• Registration Number: NCT00608101
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-06
• Study Start: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Fludrocortisone	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.
2	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
catecholamines	1 year