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

Arm | Intervention/treatment |
---|---|
Experimental: 1
Hyperinsulinemic euglycemic or hypoglycemic clamp with Muscle and skin sympathetic nerve activity recording in arm and/or leg
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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
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Procedure: moderate exercise
90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia |
- Muscle sympathetic nerve activity [ Time Frame: 2 hours ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Stephen N. Davis, MD | Vanderbilt University |
Responsible Party: | Steve Davis, Chairman of Medicine, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00608348 |
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 |
exercise hypoglycemia sympathetic nerve activity |
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |