NCT00954109

Brief Summary

The overall aim of the project is to determine whether or not exercise influences cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance or type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

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

August 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 6, 2015

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

August 4, 2009

Results QC Date

January 8, 2015

Last Update Submit

April 3, 2015

Conditions

Insulin Resistance

Keywords

Insulin ResistanceType 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Insulin Sensitivity After 5-7 Days of Exercise

    Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of \[(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).

    baseline and 24h after 5-7 days of exercise

  • Blood Flow in Response to Oral Glucose Tolerance Tests

    Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)

    pre and 24 hours post 5-7 days of exercise

Study Arms (1)

Exercise

EXPERIMENTAL

exercise - supervised exercise (treadmill walking or cycle ergometer use)

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

daily exercise: supervised treadmill walking or cycle ergometry use

Exercise

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose \>/= 100 mg/dL
  • T2D: diagnosed by primary care physician
  • BMI: less than 43 kg/m2
  • Age: 30-65

You may not qualify if:

  • Smoking
  • Insulin use (other than once daily)
  • Underlying conditions that limit ability to exercise safely
  • Recent weight gain or loss (\>5% of body weight in 3 months)
  • Physically active (\>30 min aerobic exercise, 2 d/wk)
  • Recent (\<3 mo) changes in medication use or dose
  • Uncontrolled T2D (HbA1c\>10%)
  • Advanced retinopathy or neuropathy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harry S. Truman Memorial VA Medical Center

Columbia, Missouri, 65201-5297, United States

Location

Related Publications (2)

  • Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.

    PMID: 21737826RESULT

  • Mikus CR, Oberlin DJ, Libla J, Boyle LJ, Thyfault JP. Glycaemic control is improved by 7 days of aerobic exercise training in patients with type 2 diabetes. Diabetologia. 2012 May;55(5):1417-23. doi: 10.1007/s00125-012-2490-8. Epub 2012 Feb 4.

    PMID: 22311420DERIVED

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
John Thyfault, Associate Professor
Organization
Harry S Truman Memorial VA Hospital and University of Missouri
thyfaultj@health.missouri.edu
573-814-6000

Study Officials

  • John Thyfault, PhD

    Harry S. Truman Memorial VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 7, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 6, 2015

Results First Posted

April 6, 2015

Record last verified: 2015-04

Locations

US(1)