NCT00608348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

6.3 years

First QC Date

January 29, 2008

Last Update Submit

June 9, 2015

Conditions

Diabetes Mellitus

Keywords

exercisehypoglycemiasympathetic nerve activity

Outcome Measures

Primary Outcomes (1)

  • Muscle sympathetic nerve activity

    2 hours

Study Arms (2)

1

EXPERIMENTAL

Hyperinsulinemic euglycemic or hypoglycemic clamp with Muscle and skin sympathetic nerve activity recording in arm and/or leg

Procedure: Hyperinsulinemic glucose clamp procedures

2

EXPERIMENTAL

Exercise with insulin or no insulin infused with muscle and skin sympathetic nerve activity measurements

Procedure: moderate exercise

Interventions

Hyperinsulinemic glucose clamp proceduresPROCEDURE

2 hours of either euglycemic or hypoglycemic glucose clamping

1
moderate exercisePROCEDURE

90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia

2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMotor ActivityHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Stephen N. Davis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 6, 2008

Study Start

April 1, 2002

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

US(1)