Blood GlucoseNCT02536066
Daily Physical Activity After Meals -Long Term Effects on Blood Glucose
A study testing Postprandial physical activity in people with Blood Glucose and Blood Glucose Related Variables, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
The postprandial blood glucose concentration is an important risk factor for development of cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate or light post-meal physical activity effectively blunts the postprandial increase in blood glucose after carbohydrate intake. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Glucose, Blood Glucose Related Variables
- What is being tested?
- Postprandial physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hyperglycemia or high risk of type 2 diabetes due to Ramachandrans risk score
Who cannot join
- Use of hypoglycemic agents and conditions directly affecting blood glucose other than hyperglycemia per s.e. / diabetes type 2
Trial locations and contacts
1 site in 1 country.
About this study
The postprandial blood glucose concentration is an important risk factor for development of cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate or light post-meal physical activity effectively blunts the postprandial increase in blood glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light physical activity decreases postprandial glycemia when performed in the postprandial period. The purpose of this study was to investigate whether such activity performed each day for 12 weeks would influence blood variables related to glycemic control.
METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an intervention or a control group. They were previously diagnosed as hyperglycemic, or with high risk of type 2 diabetes according to Ramachandran's risc score.
Read more
Control subjects were told to maintain their usual physical activity patterns during the study period, while the intervention subjects were instructed to undertake a minimum of 30 minutes of daily post-meal physical activity in addition to their usual activity patterns.
Venous blood samples were taken before and after the 12 week intervention period. Plasma was analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide. The subjects kept a physical activity diary, answered questionnaires and used accelerometers to determine the level of physical activity.
- Conditions
- Blood Glucose, Blood Glucose Related Variables
- Being tested
- Postprandial physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postprandial physical activityBehavioural
Adding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | maintain usual physical activity patterns |
| Intervention | Experimental | Addition of daily postprandial physical activity in addition to usual activity patterns Receives: Behavioral: Postprandial physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hba1c
Measured: Pre and post intervention which lasts an average of 12 weeks
Change in Fasted glucose
Measured: Pre and post intervention which lasts an average of 12 weeks
Change in 2hour glucose
Oral glucose tolerance test (OGTT)
Measured: Pre and post intervention which lasts an average of 12 weeks
Change in glucose during OGTT
glucose measured by finger sticks every 15. minute during the 2hour oral glucose tolerance test
Measured: Pre and post intervention which lasts an average of 12 weeks
Change in Physical fitness measured as heart rate during an exercise test
Heart rate measured at the end of 10 minutes ergometer cycle test an given intensity (low) to moderate intensity)
Measured: Measured pre and post intervention which lasts an average of 12 weeks
Change in Physical fitness measured as oxygen consumption during an exercise test
measured at the end of 10 minutes ergometer cycle test an given intensity (low) by indirect calorimetry
Measured: Measured pre and post intervention which lasts an average of 12 weeks
Change in Physical fitness measured as respiratory exchange rate during an exercise test
Measured at the end of 10 minutes ergometer cycle test an given intensity (low), by indirect calorimetry
Measured: Measured pre and post intervention which lasts an average of 12 weeks
Change in Physical fitness measured as perceived exertion during an exercise test
Borg RPE scale measured at the end of 10 minutes ergometer cycle test an given intensity (low)
Measured: Measured pre and post intervention which lasts an average of 12 weeks
Change in Physical fitness measured as lactic acid during an exercise test
measured at the end of 10 minutes ergometer cycle test an given intensity (low) from capillary blod from a finger stick
Measured: Measured pre and post intervention which lasts an average of 12 weeks
Secondary outcomes (8)
Change in Total cholesterol
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in LDL cholesterol
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in HDL cholesterol
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in triglycerides
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in body weight
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in waist circumference
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in Blood pressure
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Change in Quality of life
Quality of life measured by SF36
Measured: Measured Pre and post intervention which lasts an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- håvard nygaard, msc, Principal investigator, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536066
- Sponsor's protocol ID
- PPPA99
- Status last verified
- Aug 2015
- First submitted
- 21 May 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Physical Activity After Meals -Long Term Effects on Blood Glucose
- ClinicalTrials.gov ID
- NCT02536066
- Acronym / sponsor ID
- PPPA99
- Conditions
- Blood Glucose, Blood Glucose Related Variables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Aug 2015 (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 postprandial blood glucose concentration is an important risk factor for development of cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate or light post-meal physical activity effectively blunts the postprandial increase in blood glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light physical activity decreases postprandial glycemia when performed in the postprandial period. The purpose of this study was to investigate whether such activity performed each day for 12 weeks would influence blood variables related to glycemic control.
METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an intervention or a control group. They were previously diagnosed as hyperglycemic, or with high risk of type 2 diabetes according to Ramachandran's risc score.
Control subjects were told to maintain their usual physical activity patterns during the study period, while the intervention subjects were instructed to undertake a minimum of 30 minutes of daily post-meal physical activity in addition to their usual activity patterns.
Venous blood samples were taken before and after the 12 week intervention period. Plasma was analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide. The subjects kept a physical activity diary, answered questionnaires and used accelerometers to determine the level of physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –maintain usual physical activity patterns |
| Intervention | Experimental | Behavioral: Postprandial physical activityAddition of daily postprandial physical activity in addition to usual activity patterns |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hyperglycemia or high risk of type 2 diabetes due to Ramachandrans risk score
Key exclusion criteria (1 listed)
- Use of hypoglycemic agents and conditions directly affecting blood glucose other than hyperglycemia per s.e. / diabetes type 2
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 |
|---|---|---|
| Postprandial physical activityAdding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily | Behavioural | Intervention |
Primary outcome
Change in Hba1c
Time frame: Pre and post intervention which lasts an average of 12 weeks
Change in Fasted glucose
Time frame: Pre and post intervention which lasts an average of 12 weeks
Change in 2hour glucose
Time frame: Pre and post intervention which lasts an average of 12 weeks
Oral glucose tolerance test (OGTT)
Change in glucose during OGTT
Time frame: Pre and post intervention which lasts an average of 12 weeks
glucose measured by finger sticks every 15. minute during the 2hour oral glucose tolerance test
Change in Physical fitness measured as heart rate during an exercise test
Time frame: Measured pre and post intervention which lasts an average of 12 weeks
Heart rate measured at the end of 10 minutes ergometer cycle test an given intensity (low) to moderate intensity)
Change in Physical fitness measured as oxygen consumption during an exercise test
Time frame: Measured pre and post intervention which lasts an average of 12 weeks
measured at the end of 10 minutes ergometer cycle test an given intensity (low) by indirect calorimetry
Change in Physical fitness measured as respiratory exchange rate during an exercise test
Time frame: Measured pre and post intervention which lasts an average of 12 weeks
Measured at the end of 10 minutes ergometer cycle test an given intensity (low), by indirect calorimetry
Change in Physical fitness measured as perceived exertion during an exercise test
Time frame: Measured pre and post intervention which lasts an average of 12 weeks
Borg RPE scale measured at the end of 10 minutes ergometer cycle test an given intensity (low)
Change in Physical fitness measured as lactic acid during an exercise test
Time frame: Measured pre and post intervention which lasts an average of 12 weeks
measured at the end of 10 minutes ergometer cycle test an given intensity (low) from capillary blod from a finger stick
8 secondary outcomes
Change in Total cholesterol
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in LDL cholesterol
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in HDL cholesterol
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in triglycerides
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in body weight
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in waist circumference
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in Blood pressure
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
Change in Quality of life
Time frame: Measured Pre and post intervention which lasts an average of 12 weeks
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 31 Aug 2015.
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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.
håvard nygaard, msc principal investigator
Inland Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postprandial physical activity in people with Blood Glucose and Blood Glucose Related Variables, run by Inland Norway University of Applied Sciences at 1 site 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 1 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 31 Aug 2015. 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 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?
Change in Hba1c (time frame: Pre and post intervention which lasts an average of 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2015.