Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

NCT00608101 | Withdrawn

• 2 other identifiers: IRB #040907-HAAF in T1DM, Q1R01DK069803-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes

Keywords

hypoglycemia; exercise; corticosteroids

Outcome Measures

Primary Outcomes (1)

• catecholamines

  1 year

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

Fludrocortisone DRUG

Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1

1

Dexamethasone DRUG

Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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
• (8 males, 8 females) Healthy volunteers aged 18-45 yrs.
• Body mass index \< 27kg · m-2

You may not qualify if:

• Prior or current history of poor health
• Abnormal results following blood and physical examination
• Pregnancy

Sponsors & Collaborators

• Vanderbilt University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Interventions

Fludrocortisone; Dexamethasone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Hydrocortisone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Steroids, Fluorinated

Study Officials

• Stephen N. Davis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: September 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 11, 2014

Record last verified: 2014-12