Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

Official title:

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00608101
• Other study ID #: IRB #040907-HAAF in T1DM, Q1
• Secondary ID: RO1 DK 069803-03
• Status: Withdrawn
• Phase: N/A
• First received: January 23, 2008
• Last updated: December 10, 2014
• Start date: September 2010
• Est. completion date: September 2010

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Pure Autonomic Failure
• Type 1 Diabetes

Intervention

Drug:
• Fludrocortisone
Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
• Dexamethasone
Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catecholamines		1 year	No