NCT01987687

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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

November 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
3 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

November 13, 2013

Last Update Submit

August 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose concentration area under the curve

    Blood glucose concentrations will be sampled every 15 min following an oral glucose tolerance test.

    90 min

Secondary Outcomes (1)

  • Postprandial insulin concentration area under the curve

    90 min

Study Arms (3)

Rest

ACTIVE COMPARATOR

Breakfast followed by a rest period prior to OGTT.

Behavioral: Rest

Exercise-immediate

EXPERIMENTAL

Breakfast followed by exercise and an immediate OGTT

Behavioral: Exercise

Exercise-delay

EXPERIMENTAL

Breakfast followed by exercise and a delayed (1 h) OGTT.

Behavioral: ExerciseBehavioral: Delay

Interventions

ExerciseBEHAVIORAL

Exercise at 55% of maximum power output for 30 min.

Exercise-delayExercise-immediate
RestBEHAVIORAL

Rest for 30 min

Rest
DelayBEHAVIORAL

Delay between exercise and OGTT

Exercise-delay

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Contraindications to exercise
  • Food intolerances
  • Food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (2)

  • Gonzalez JT, Stevenson EJ. Assessment of the post-exercise glycemic response to food: considering prior nutritional status. Nutrition. 2014 Jan;30(1):122-3. doi: 10.1016/j.nut.2013.05.015. Epub 2013 Sep 18. No abstract available.

    PMID: 24054351BACKGROUND
  • Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.

    PMID: 23340006BACKGROUND

MeSH Terms

Interventions

ExerciseRE1-silencing transcription factor

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Javier T Gonzalez, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 19, 2013

Study Start

November 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations