Sympathetic Nerve Activity During Hypoglycemia and Exercise - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00608348

Purpose

The purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity.

Condition	Intervention
Diabetes Mellitus	Procedure: Hyperinsulinemic glucose clamp procedures Procedure: moderate exercise

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Factorial Assignment
Official Title:	Sympathetic Nerve Activity During Hypoglycemia and Exercise

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Muscle sympathetic nerve activity [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2002
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hyperinsulinemic euglycemic or hypoglycemic clamp with Muscle and skin sympathetic nerve activity recording in arm and/or leg	Procedure: Hyperinsulinemic glucose clamp procedures 2 hours of either euglycemic or hypoglycemic glucose clamping
2: Experimental Exercise with insulin or no insulin infused with muscle and skin sympathetic nerve activity measurements	Procedure: moderate exercise 90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia

Detailed Description:

The body has defensive responses to correct low blood sugar (hypoglycemia). A vital component of this response is release of glucagon and activation of the sympathetic nervous system, which provides the means for raising blood glucose levels towards normal. We can measure circulating hormones indicating the level of these responses, but additionally, sympathetic nervous system responses can be measured directly. We can measure the sympathetic nerve activity that controls blood flow to muscles (MSNA) and blood flow and sweating to skin (SSNA). The purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity. We would also like to determine what the sympathetic response is to cycling exercise with insulin and normal blood sugar. Therefore, we would like to test the sympathetic responses to insulin with normal blood glucose, hypoglycemia, and during exercise bouts and normal blood glucose, with or without insulin.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

36 Healthy male and female subjects (18 males and 18 females) aged 18-40 yr
All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities
Body mass index ≤30kg · m-2
Normal bedside autonomic function
Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.

Exclusion Criteria:

Pregnant women
Subjects unable to give voluntary informed consent
Subjects on anticoagulant drugs or anemic
Subjects with a recent medical illness
Subjects with a history of hypertension, heart disease or cerebrovascular disease
Subjects with known liver or kidney disease
Subjects with recent weight loss or consuming a low carbohydrate diet

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608348

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB#020777-SNA during hypo/ex
Study First Received:	January 29, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00608348
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

exercise
hypoglycemia
sympathetic nerve activity

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

ClinicalTrials.gov processed this record on February 12, 2009