Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00608101
Recruitment Status : Withdrawn
First Posted : February 6, 2008
Last Update Posted : December 11, 2014
Information provided by (Responsible Party):
Steve Davis, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Fludrocortisone Drug: Dexamethasone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Official Title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1
Study Start Date : September 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. catecholamines [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00608101

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

Responsible Party: Steve Davis, Department Chair, Vanderbilt University Identifier: NCT00608101     History of Changes
Other Study ID Numbers: IRB #040907-HAAF in T1DM, Q1
R01DK069803-03 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Steve Davis, Vanderbilt University:

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