NCT00972452

Brief Summary

The investigators wish to determine whether a short period of exercise training (5-10 days) improves the metabolic and cardiovascular response of people with or at risk of developing type 2 diabetes to eating a meal. In healthy people, blood flow to skeletal muscles increases after eating a meal, and this helps to regulate blood sugar levels by delivering blood sugar to muscles where it can be stored or metabolized. In people with or at risk of type 2 diabetes, blood flow does not increase as much after eating a meal, and this may contribute to elevated blood sugar concentrations observed in these individuals. The investigators wish to determine whether exercise can improve this response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

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
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 4, 2009

Last Update Submit

September 23, 2015

Conditions

Type 2 DiabetesInsulin Resistance

Keywords

Type II DiabetesInsulin ResistanceExerciseContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.

    2 hours

Study Arms (1)

Exercise

EXPERIMENTAL

5-10d exercise training

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

short period of exercise training (5-10 days)

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)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • 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

  • 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: 21737826DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John P Thyfault, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 7, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

September 1, 2010

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

US(1)