Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

December 10, 2014 updated by: Steve Davis, Vanderbilt University

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
catecholamines
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (ESTIMATE)

February 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #040907-HAAF in T1DM, Q1
  • R01DK069803-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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