Hypoglycemia and Autonomic Nervous System Function

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-08

Study Completion Date

2007-11-06

Brief Summary

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The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.

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Detailed Description

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Conditions

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Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Euglycemic hyperinsulinemic clamp

participant undergoes a euglycemic hyperinsulinemic clamp

Group Type SHAM_COMPARATOR

Euglycemic hyperinsulinemic clamp

Intervention Type OTHER

Hypoglycemic hyperinsulinemic clamp

participant undergoes a hypoglycemic hyperinsulinemic clamp

Group Type ACTIVE_COMPARATOR

Hypoglycemic hyperinsulinemic clamp

Intervention Type OTHER

Interventions

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Hypoglycemic hyperinsulinemic clamp

Intervention Type OTHER

Euglycemic hyperinsulinemic clamp

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Males and females age 18 to 50 years

Exclusion Criteria

* Pregnancy
* Lactation
* Subjects who smoke or are on other forms of nicotine will be excluded
* Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
* Current major depressive illness
* Any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
* Use of medications other than thyroxine

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes