Diabetes MellitusNCT00608348
Sympathetic Nerve Activity During Hypoglycemia and Exercise
A study testing Hyperinsulinemic glucose clamp procedures and moderate exercise in people with Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Hyperinsulinemic glucose clamp procedures and moderate exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Hyperinsulinemic glucose clamp procedures, moderate exercise
- Keywords
- exercise, hypoglycemia, sympathetic nerve activity
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic glucose clamp proceduresProcedure or surgery
2 hours of either euglycemic or hypoglycemic glucose clamping
moderate exerciseProcedure or surgery
90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hyperinsulinemic euglycemic or hypoglycemic clamp with Muscle and skin sympathetic nerve activity recording in arm and/or leg Receives: Procedure: Hyperinsulinemic glucose clamp procedures |
| 2 | Experimental | Exercise with insulin or no insulin infused with muscle and skin sympathetic nerve activity measurements Receives: Procedure: moderate exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sympathetic nerve activity
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startApr 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Davis, Vanderbilt University
- Investigators
- Stephen N. Davis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608348
- Sponsor's protocol ID
- IRB#020777-SNA during hypo/ex
- Status last verified
- Jun 2015
- First submitted
- 29 Jan 2008
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Nerve Activity During Hypoglycemia and Exercise
- ClinicalTrials.gov ID
- NCT00608348
- Acronym / sponsor ID
- IRB#020777-SNA during hypo/ex
- Conditions
- Diabetes Mellitus
- Keywords
- exercise, hypoglycemia, sympathetic nerve activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity.
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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Hyperinsulinemic glucose clamp proceduresHyperinsulinemic euglycemic or hypoglycemic clamp with Muscle and skin sympathetic nerve activity recording in arm and/or leg |
| 2 | Experimental | Procedure: moderate exerciseExercise with insulin or no insulin infused with muscle and skin sympathetic nerve activity measurements |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulinemic glucose clamp procedures2 hours of either euglycemic or hypoglycemic glucose clamping | Procedure or surgery | 1 |
| moderate exercise90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia | Procedure or surgery | 2 |
Primary outcome
Muscle sympathetic nerve activity
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N. Davis, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic glucose clamp procedures and moderate exercise in people with Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle sympathetic nerve activity (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.