Sympathetic Nerve Activity During Hypoglycemia and Exercise

Diabetes Mellitus Clinical Trial

Official title:

Sympathetic Nerve Activity During Hypoglycemia and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608348
• Other study ID #: IRB#020777-SNA during hypo/ex
• Status: Completed
• Phase: N/A
• First received: January 29, 2008
• Last updated: June 9, 2015
• Start date: April 2002
• Est. completion date: July 2008

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypoglycemia

Intervention

Procedure:
• Hyperinsulinemic glucose clamp procedures
2 hours of either euglycemic or hypoglycemic glucose clamping
• moderate exercise
90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle sympathetic nerve activity		2 hours	No