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Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987687
Recruitment Status : Suspended (Lack of funding)
First Posted : November 19, 2013
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, PhD, Northumbria University

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 19, 2013
Last Update Posted Date August 29, 2014
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
Postprandial glucose concentration area under the curve [ Time Frame: 90 min ]
Blood glucose concentrations will be sampled every 15 min following an oral glucose tolerance test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
Postprandial insulin concentration area under the curve [ Time Frame: 90 min ]
Insulin concentrations will be determine every 15 min following an oral glucose tolerance test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
Official Title  ICMJE Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
Brief Summary

Postprandial glycaemic control is an important risk factor for the development of type 2 diabetes, cardiovascular disease and all-cause mortality.

Previous research has demonstrated that exercise performed in the postprandial state paradoxically results in a deterioration in glucose tolerance in the immediate post-exercise period (Gonzalez et a. 2013; Gonzalez and Stevenson 2013). This study aims to assess the timecourse of this post-exercise effect.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Area Under Curve [N06.850.520.830.200]
Intervention  ICMJE
  • Behavioral: Exercise
    Exercise at 55% of maximum power output for 30 min.
  • Behavioral: Rest
    Rest for 30 min
  • Behavioral: Delay
    Delay between exercise and OGTT
Study Arms  ICMJE
  • Active Comparator: Rest
    Breakfast followed by a rest period prior to OGTT.
    Intervention: Behavioral: Rest
  • Experimental: Exercise-immediate
    Breakfast followed by exercise and an immediate OGTT
    Intervention: Behavioral: Exercise
  • Experimental: Exercise-delay
    Breakfast followed by exercise and a delayed (1 h) OGTT.
    Interventions:
    • Behavioral: Exercise
    • Behavioral: Delay
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal weight (18-25 kg/m2)
  • Physically active (>or= 3 times per week)
  • Male

Exclusion Criteria:

  • Contraindications to exercise
  • Food intolerances
  • Food allergies
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987687
Other Study ID Numbers  ICMJE 32W7
32W7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javier Gonzalez, PhD, Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Javier T Gonzalez, PhD Northumbria University
PRS Account Northumbria University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP