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Sympathetic Nerve Activity During Hypoglycemia and Exercise

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ClinicalTrials.gov Identifier: NCT00608348
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: Hyperinsulinemic glucose clamp procedures Procedure: moderate exercise Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Sympathetic Nerve Activity During Hypoglycemia and Exercise
Study Start Date : April 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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
Experimental: 2
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


Outcome Measures
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Primary Outcome Measures :
  1. Muscle sympathetic nerve activity [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Steve Davis, Chairman of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608348     History of Changes
Other Study ID Numbers: IRB#020777-SNA during hypo/ex
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Steve Davis, Vanderbilt University:
exercise
hypoglycemia
sympathetic nerve activity

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases