Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University
ClinicalTrials.gov Identifier:
First received: January 23, 2008
Last updated: December 10, 2014
Last verified: December 2014
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.

Condition Intervention
Type 1 Diabetes
Drug: Fludrocortisone
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • catecholamines [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Fludrocortisone
Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
Experimental: 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.
Drug: Dexamethasone
Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00608101

Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
  More Information

Responsible Party: Steve Davis, Department Chair, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608101     History of Changes
Other Study ID Numbers: IRB #040907-HAAF in T1DM, Q1  RO1 DK 069803-03 
Study First Received: January 23, 2008
Last Updated: December 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Pure Autonomic Failure
Autoimmune Diseases
Autonomic Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Primary Dysautonomias
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016