Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00608101

Enrollment

Registered

2008-02-06

Start date

2010-09-30

Completion date

2010-09-30

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

hypoglycemia, exercise, corticosteroids

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.

Interventions

DRUGFludrocortisone

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

DRUGDexamethasone

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
catecholamines	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026