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Completed

NCT Number: NCT00608348

Sympathetic Nerve Activity During Hypoglycemia and Exercise

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperinsulinemic glucose clamp procedures

Procedure

2 hours of either euglycemic or hypoglycemic glucose clamping

moderate exercise

Procedure

90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia

Primary outcomes

  1. Muscle sympathetic nerve activity

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2008
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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