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Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00608816
Enrollment
0
Registered
2008-02-06
Start date
Unknown
Completion date
Unknown
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

epinephrine

Brief summary

Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Detailed description

When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened. This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences. Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Interventions

DRUGepinephrine

Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C \> 8.5% * 28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C \< 7% * 28 (14 males, 14 females) non-diabetic controls * Age 18-45 yr. * Had diabetes for 2-15 years if diabetic subject * No clinical evidence of diabetic tissue complications, no cardiovascular disease * Body mass index 21-27kg · m-2 * Normal bedside autonomic function * Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities * Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion criteria

* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease * Hemoglobin of less than 12 g/dl * Abnormal results following screening tests * Pregnancy * Subjects unable to give voluntary informed consent * Subjects with a recent medical illness * Subjects with known liver or kidney disease * Subjects taking steroids * Subjects taking beta blockers * Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Design outcomes

Primary

MeasureTime frame
catecholamine levels2 days

Outcome results

None listed

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