Type 2 DiabetesNCT02180620
Pre-dinner vs. Post-dinner Exercise on Glycemic Control
A study testing No exercise, Meal then exercise and exercise then meal in people with Type 2 Diabetes, run by University of Missouri-Columbia.
Trial summary
With many medications we prescribe them relative to time of day or a meal. This study established if pre dinner vs post dinner exercise was more effective at altering post dinner glucose and triglyceride levels vs no exercise at all. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- No exercise, Meal then exercise and exercise then meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Apr 2014
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese ( body mass index 30-45 kg/m2)
- Physician diagnosed with type 2 diabetes receiving standard medical care
- Non-smokers
- Pregnancy
- Lactating mothers
Who cannot join
- Insulin
- Surgical weight loss
- Orthopedic limitations to exercise
- Weight loss in the previous 3 months
About this study
Official title: Exercise Timing and Postprandial Glycemia in Type 2 Diabetes
With many medications we prescribe them relative to time of day or a meal. This study established if pre dinner vs post dinner exercise was more effective at altering post dinner glucose and triglyceride levels vs no exercise at all.
Read the detailed description
All participants completed three trials in a random order in which they consumed a standardized dinner meal with 1) no RE (NoRE), 2) pre-dinner RE (RE→M), and 3) post-dinner RE beginning 45 min after dinner (M→RE). Diet was standardized during the day of testing. Participants reported to the lab for testing sometime between 3 - 5:30 p.m. and upon arrival a venous catheter was inserted into a forearm vein. Frequent blood sampling, indirect calorimetry measurements, and subjective well-being measurements ensued for ~5.75 h while the participants were in the lab.
- Conditions
- Type 2 Diabetes
- Being tested
- No exercise, Meal then exercise, exercise then meal
- Keywords
- GIP, GLP-1, exercise timing, resistance exercise, glucose concentrations
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No exerciseOther
Also called NoEX
During the no exercise trial (NoEX), the participants will remain sedentary during testing.
Meal then exerciseOther
Also called M-EX
During the post-meal exercise trial (M→EX), 45 min of resistance training will be performed
exercise then mealOther
Also called EX-M
During the exercise prior to the meal trial (EX→M), 45 min of resistance training will be performed
| Study group | Role | What they receive |
|---|---|---|
| No exercise | Experimental | participants will remain sedentary during testing Receives: Other: No exercise |
| Meal then exercise | Experimental | 45 min of resistance training will be performed after a standard meal Receives: Other: Meal then exercise |
| exercise then meal | Experimental | 45 min of resistance training will be performed prior to a standard meal Receives: Other: exercise then meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose concentrations
Measured: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
Secondary outcomes (1)
triglyceride concentrations
Measured: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180620
- Sponsor's protocol ID
- exertime
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2014
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heden TD, Liu Y, Kanaley JA. A comparison of adipose tissue interstitial glucose and venous blood glucose during postprandial resistance exercise in patients with type 2 diabetes. J Appl Physiol (1985). 2018 Apr 1;124(4):1054-1061. doi: 10.1152/japplphysiol.00475.2017. Epub 2017 Sep 28.
PubMed 28970202
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Timing and Postprandial Glycemia in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02180620
- Acronym / sponsor ID
- exertime
- Conditions
- Type 2 Diabetes
- Keywords
- GIP, GLP-1, exercise timing, resistance exercise, glucose concentrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Jul 2014 (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.
With many medications we prescribe them relative to time of day or a meal. This study established if pre dinner vs post dinner exercise was more effective at altering post dinner glucose and triglyceride levels vs no exercise at all.
Detailed description
All participants completed three trials in a random order in which they consumed a standardized dinner meal with 1) no RE (NoRE), 2) pre-dinner RE (RE→M), and 3) post-dinner RE beginning 45 min after dinner (M→RE). Diet was standardized during the day of testing. Participants reported to the lab for testing sometime between 3 - 5:30 p.m. and upon arrival a venous catheter was inserted into a forearm vein. Frequent blood sampling, indirect calorimetry measurements, and subjective well-being measurements ensued for ~5.75 h while the participants were in the lab.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No exercise | Experimental | Other: No exerciseparticipants will remain sedentary during testing |
| Meal then exercise | Experimental | Other: Meal then exercise45 min of resistance training will be performed after a standard meal |
| exercise then meal | Experimental | Other: exercise then meal45 min of resistance training will be performed prior to a standard meal |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Obese ( body mass index 30-45 kg/m2)
- Physician diagnosed with type 2 diabetes receiving standard medical care
- Non-smokers
- Pregnancy
- Lactating mothers
Key exclusion criteria (4 listed)
- Insulin
- Surgical weight loss
- Orthopedic limitations to exercise
- Weight loss in the previous 3 months
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 |
|---|---|---|
| No exerciseAlso: NoEXDuring the no exercise trial (NoEX), the participants will remain sedentary during testing. | Other | No exercise |
| Meal then exerciseAlso: M-EXDuring the post-meal exercise trial (M→EX), 45 min of resistance training will be performed | Other | Meal then exercise |
| exercise then mealAlso: EX-MDuring the exercise prior to the meal trial (EX→M), 45 min of resistance training will be performed | Other | exercise then meal |
Primary outcome
glucose concentrations
Time frame: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
1 secondary outcome
triglyceride concentrations
Time frame: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Derived from this study: PubMed 28970202Heden TD, Liu Y, Kanaley JA. A comparison of adipose tissue interstitial glucose and venous blood glucose during postprandial resistance exercise in patients with type 2 diabetes. J Appl Physiol (1985). 2018 Apr 1;124(4):1054-1061. doi: 10.1152/japplphysiol.00475.2017. Epub 2017 Sep 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing No exercise, Meal then exercise and exercise then meal in people with Type 2 Diabetes, run by University of Missouri-Columbia.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glucose concentrations (time frame: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h). 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 NCT02180620, which also lists 1 linked publication.
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 8 Jun 2017.