Area Under Curve [N06.850.520.830.200]NCT01987687
Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
A study testing Exercise, Rest and Delay in people with Area Under Curve [N06.850.520.830.200], run by Northumbria University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Area Under Curve [N06.850.520.830.200]
- What is being tested?
- Exercise, Rest and Delay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight (18-25 kg/m2)
- Physically active (>or= 3 times per week)
- Male
Who cannot join
- Contraindications to exercise
- Food intolerances
- Food allergies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
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.
- Conditions
- Area Under Curve [N06.850.520.830.200]
- Being tested
- Exercise, Rest, Delay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise at 55% of maximum power output for 30 min.
RestBehavioural
Rest for 30 min
DelayBehavioural
Delay between exercise and OGTT
| Study group | Role | What they receive |
|---|---|---|
| Rest | Active comparator | Breakfast followed by a rest period prior to OGTT. Receives: Behavioral: Rest |
| Exercise-immediate | Experimental | Breakfast followed by exercise and an immediate OGTT Receives: Behavioral: Exercise |
| Exercise-delay | Experimental | Breakfast followed by exercise and a delayed (1 h) OGTT. Receives: Behavioral: Exercise; Behavioral: Delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose concentration area under the curve
Blood glucose concentrations will be sampled every 15 min following an oral glucose tolerance test.
Measured: 90 min
Secondary outcomes (1)
Postprandial insulin concentration area under the curve
Insulin concentrations will be determine every 15 min following an oral glucose tolerance test.
Measured: 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startNov 2016
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Area Under Curve [N06.850.520.830.200]Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, PhD, Northumbria University
- Investigators
- Javier T Gonzalez, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987687
- Sponsor's protocol ID
- 32W7
- Other IDs
- 32W7
- Status last verified
- Aug 2014
- First submitted
- 13 Nov 2013
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24054351Gonzalez 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.
PubMed 23340006
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
- ClinicalTrials.gov ID
- NCT01987687
- Acronym / sponsor ID
- 32W7
- Conditions
- Area Under Curve [N06.850.520.830.200]
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of funding
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rest | Active comparator | Behavioral: RestBreakfast followed by a rest period prior to OGTT. |
| Exercise-immediate | Experimental | Behavioral: ExerciseBreakfast followed by exercise and an immediate OGTT |
| Exercise-delay | Experimental | Behavioral: Exercise, Behavioral: DelayBreakfast followed by exercise and a delayed (1 h) OGTT. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal weight (18-25 kg/m2)
- Physically active (>or= 3 times per week)
- Male
Key exclusion criteria (3 listed)
- Contraindications to exercise
- Food intolerances
- Food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise at 55% of maximum power output for 30 min. | Behavioural | Exercise-delay, Exercise-immediate |
| RestRest for 30 min | Behavioural | Rest |
| DelayDelay between exercise and OGTT | Behavioural | Exercise-delay |
Primary outcome
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.
1 secondary outcome
Postprandial insulin concentration area under the curve
Time frame: 90 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Background: PubMed 24054351Gonzalez 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.
- Background: PubMed 23340006Gonzalez 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier T Gonzalez, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Rest and Delay in people with Area Under Curve [N06.850.520.830.200], run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose concentration area under the curve (time frame: 90 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.