Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
NCT ID: NCT00608101
Last Updated: 2014-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SINGLE
Study Groups
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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.
Fludrocortisone
Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
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.
Dexamethasone
Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 ยท m-2
Exclusion Criteria
* Abnormal results following blood and physical examination
* Pregnancy
18 Years
45 Years
ALL
Yes
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Steve Davis
Department Chair
Principal Investigators
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Stephen N. Davis, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Other Identifiers
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IRB #040907-HAAF in T1DM, Q1
Identifier Type: -
Identifier Source: org_study_id