Diabetes Mellitus, Type 2NCT01991769
Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
A study testing 47 min moderate intensity training and exercise healthy volunteers in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function. Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 47 min moderate intensity training and exercise healthy volunteers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2012to Nov 2013
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy or type 2 diabetes
Who cannot join
- type 2 diabetes more than 10 years
- unstable angina
- myocardial infarction
- overt cardiovascular disease.
- severe valvular disease.
- overt lung disease.
Show all 19Show fewer
- orthopedical- /neurological restrictions
- severe disease related to diabetes type 2 (neuropathy, micro-or macroalbuminuria, retinopathy)
- body mass index >35
- severe eating disorders.
- personality disturbances.
- planned surgery during the project period.
- patients who achieve greater than the current exercise guidelines for type 2 diabetes (210 min/week) before the start of the study.
- uncontrolled hypertension
- kidney failure
- cardiomyopathy
- smoking
- patients who probably not will be able to complete the study
- alcohol or drug abuse
Trial locations and contacts
2 sites in 1 country.
About this study
The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function.
Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 47 min moderate intensity training, exercise healthy volunteers, control; no exercise training
- Keywords
- exercise, endothelium, postprandial period
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
47 min moderate intensity trainingBehavioural
exercise healthy volunteersBehavioural
control; no exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| exercise diabetes type 2 | Experimental | 4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal. Receives: Behavioral: 47 min moderate intensity training; Behavioral: exercise healthy volunteers; Behavioral: control; no exercise training |
| exercise healthy volunteers | Active comparator | 4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal. Receives: Behavioral: 47 min moderate intensity training; Behavioral: exercise healthy volunteers; Behavioral: control; no exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionNov 2013
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Charlotte B Ingul, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991769
- Sponsor's protocol ID
- 2011/1801
- Status last verified
- Jun 2016
- First submitted
- 28 Oct 2013
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hollekim-Strand SM, Malmo V, Follestad T, Wisloff U, Ingul CB. Fast food increases postprandial cardiac workload in type 2 diabetes independent of pre-exercise: A pilot study. Nutr J. 2015 Aug 14;14:79. doi: 10.1186/s12937-015-0069-1.
PubMed 26272328
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
- ClinicalTrials.gov ID
- NCT01991769
- Acronym / sponsor ID
- 2011/1801
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- exercise, endothelium, postprandial period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 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.
The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function.
Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise diabetes type 2 | Experimental | Behavioral: 47 min moderate intensity training, Behavioral: exercise healthy volunteers, Behavioral: control; no exercise training4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal. |
| exercise healthy volunteers | Active comparator | Behavioral: 47 min moderate intensity training, Behavioral: exercise healthy volunteers, Behavioral: control; no exercise training4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy or type 2 diabetes
Key exclusion criteria (19 listed)
- type 2 diabetes more than 10 years
- unstable angina
- myocardial infarction
- overt cardiovascular disease.
- severe valvular disease.
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 |
|---|---|---|
| 47 min moderate intensity training | Behavioural | exercise diabetes type 2, exercise healthy volunteers |
| exercise healthy volunteers | Behavioural | exercise diabetes type 2, exercise healthy volunteers |
| control; no exercise training | Behavioural | exercise diabetes type 2, exercise healthy volunteers |
Primary outcome
endothelial function
Time frame: 24 hours
measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines
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 14 Jun 2016.
- Results publication: PubMed 26272328Hollekim-Strand SM, Malmo V, Follestad T, Wisloff U, Ingul CB. Fast food increases postprandial cardiac workload in type 2 diabetes independent of pre-exercise: A pilot study. Nutr J. 2015 Aug 14;14:79. doi: 10.1186/s12937-015-0069-1.
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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.
Charlotte B Ingul, PhD study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 47 min moderate intensity training and exercise healthy volunteers in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 1 inclusion and 19 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 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
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?
endothelial function (time frame: 24 hours). 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 NCT01991769, 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 14 Jun 2016.