Diabetes Mellitus, Type 2NCT03712501
Influence of Prior Walking on Postprandial Metabolism and Endothelial Function.
A study testing Exercise in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in healthy South Asian and White European women. Participants will complete two, 2-day trials in a random, crossover design separated by at least 3 weeks to control for the menstrual cycle phase. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to 30 Dec 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 40 year old South Asian and White European women;
- Be able to walk continuously for 1 hour;
- Weight stable for the past 3 months;
- Non-smokers;
- No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
Who cannot join
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Congenital heart disease;
- Any muscle or bone injuries that do not allow them to walk on a treadmill;
- Uncontrolled exercise-induced asthma;
- Coagulation or bleeding disorders;
- Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
Show all 13Show fewer
- Taking any medication that might influence fat metabolism;
- Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
- Heart conditions;
- Smoking;
- Dieting or restrained eating behaviours;
- Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
- A food allergy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Centre for Sport and Exercise Medicine, Loughborough University
Loughborough, LE11 3TU
About this study
Official title: Influence of Prior Walking on Postprandial Metabolism and Endothelial Function in South Asian vs White European Women.
The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in healthy South Asian and White European women.
Participants will complete two, 2-day trials in a random, crossover design separated by at least 3 weeks to control for the menstrual cycle phase.
Read more
On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.
It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.
Read the detailed description
South Asian individuals have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role.
Previous research from our laboratory has shown that coronary heart disease risk markers in the postprandial period are elevated in South Asian men, but acute exercise was equally, if not more, effective for reducing these risk markers in South Asian than White European men. However, the effect of acute exercise on coronary heart disease risk markers has not been examined in South Asian women.
Therefore, the purpose of the present study is to compare the effect of acute exercise on endothelial function and coronary heart disease risk markers in women of South Asian versus White European descent.
On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. Two preliminary exercise tests will be performed as follows: 1) submaximal-incremental treadmill walking test and 2) incremental treadmill running test to exhaustion to measure maximal oxygen uptake.
On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.
On visits 3-6 participants will complete two, 2-day trials in a random, crossover design seperated by at least 3 weeks to control for the menstrual cycle phase. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.
On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass.
Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction, Insulin Resistance, Oxidative Stress
- Being tested
- Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A 60 minute walk at 60% maximal oxygen uptake.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1. Participants will return the following day and consume a high fat breakfast and lunch. Receives: Behavioral: Exercise |
| Control | No intervention | Participants will rest on day 1. Participants will return the following day where they will consume a high fat breakfast and lunch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triacylglycerol
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h.
Secondary outcomes (12)
Endothelial function
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Measured: Day 1 fasting and 8.75h. Day 2 fasting and 3.5h.
Blood pressure
Changes in blood pressure (systolic and diastolic).
Measured: Day 1 fasting. Day 2 fasting and 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h and 9h.
Glucose
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h
Total cholesterol
Fasting plasma total cholesterol on day 1 and day 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Insulin
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h, 8h.
High-density lipoprotein cholesterol
Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Low-density lipoprotein cholesterol
Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Non-esterified fatty acids
Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h and 9h.
Interleukin-6
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
C-Reactive protein
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Peroxiredoxin-4
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Superoxide dismutase 3
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Measured: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Oct 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Principal investigator, Matthew Roberts, Loughborough University
- Investigators
- Matthew Roberts, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712501
- Sponsor's protocol ID
- R16-P188
- Status last verified
- May 2019
- First submitted
- 17 Oct 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised individual participant data for all primary and secondary outcome measures will be made available.
Publications
Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
PubMed 26438068Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
PubMed 23470315Roberts MJ, Thackray AE, Wadley AJ, Alotaibi TF, Hunter DJ, Thompson J, Fujihira K, Miyashita M, Mastana S, Bishop NC, O'Donnell E, Davies MJ, King JA, Yates T, Webb D, Stensel DJ. Effect of Acute Walking on Endothelial Function and Postprandial Lipemia in South Asians and White Europeans. Med Sci Sports Exerc. 2023 May 1;55(5):794-802. doi: 10.1249/MSS.0000000000003098. Epub 2022 Dec 5.
PubMed 36729923
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Prior Walking on Postprandial Metabolism and Endothelial Function in South Asian vs White European Women.
- ClinicalTrials.gov ID
- NCT03712501
- Acronym / sponsor ID
- R16-P188
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction, Insulin Resistance, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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 present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in healthy South Asian and White European women.
Participants will complete two, 2-day trials in a random, crossover design separated by at least 3 weeks to control for the menstrual cycle phase.
On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.
It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.
Detailed description
South Asian individuals have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role.
Previous research from our laboratory has shown that coronary heart disease risk markers in the postprandial period are elevated in South Asian men, but acute exercise was equally, if not more, effective for reducing these risk markers in South Asian than White European men. However, the effect of acute exercise on coronary heart disease risk markers has not been examined in South Asian women.
Therefore, the purpose of the present study is to compare the effect of acute exercise on endothelial function and coronary heart disease risk markers in women of South Asian versus White European descent.
On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. Two preliminary exercise tests will be performed as follows: 1) submaximal-incremental treadmill walking test and 2) incremental treadmill running test to exhaustion to measure maximal oxygen uptake.
On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.
On visits 3-6 participants will complete two, 2-day trials in a random, crossover design seperated by at least 3 weeks to control for the menstrual cycle phase. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.
On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass.
Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseParticipants will walk for 60 minutes at 60% maximal oxygen uptake on day 1. Participants will return the following day and consume a high fat breakfast and lunch. |
| Control | No intervention | –Participants will rest on day 1. Participants will return the following day where they will consume a high fat breakfast and lunch. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 40 year old South Asian and White European women;
- Be able to walk continuously for 1 hour;
- Weight stable for the past 3 months;
- Non-smokers;
- No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
Key exclusion criteria (13 listed)
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Congenital heart disease;
- Any muscle or bone injuries that do not allow them to walk on a treadmill;
- Uncontrolled exercise-induced asthma;
- Coagulation or bleeding disorders;
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 |
|---|---|---|
| ExerciseA 60 minute walk at 60% maximal oxygen uptake. | Behavioural | Exercise |
Primary outcome
Triacylglycerol
Time frame: Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h.
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
12 secondary outcomes
Endothelial function
Time frame: Day 1 fasting and 8.75h. Day 2 fasting and 3.5h.
Blood pressure
Time frame: Day 1 fasting. Day 2 fasting and 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h and 9h.
Glucose
Time frame: Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h
Total cholesterol
Time frame: Day 1 fasting. Day 2 fasting.
Insulin
Time frame: Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h, 8h.
High-density lipoprotein cholesterol
Time frame: Day 1 fasting. Day 2 fasting.
Low-density lipoprotein cholesterol
Time frame: Day 1 fasting. Day 2 fasting.
Non-esterified fatty acids
Time frame: Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h and 9h.
Interleukin-6
Time frame: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
C-Reactive protein
Time frame: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Peroxiredoxin-4
Time frame: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Superoxide dismutase 3
Time frame: Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
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 May 2019.
- Background: PubMed 26438068Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
- Background: PubMed 23470315Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
- Derived from this study: PubMed 36729923Roberts MJ, Thackray AE, Wadley AJ, Alotaibi TF, Hunter DJ, Thompson J, Fujihira K, Miyashita M, Mastana S, Bishop NC, O'Donnell E, Davies MJ, King JA, Yates T, Webb D, Stensel DJ. Effect of Acute Walking on Endothelial Function and Postprandial Lipemia in South Asians and White Europeans. Med Sci Sports Exerc. 2023 May 1;55(5):794-802. doi: 10.1249/MSS.0000000000003098. Epub 2022 Dec 5.
- Individual participant dataSharing planned: Undecided. Anonymised individual participant data for all primary and secondary outcome measures will be made available.
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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.
Matthew Roberts principal investigator
Loughborough 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 in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Loughborough 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 5 inclusion and 13 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 May 2019. 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?
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?
Triacylglycerol (time frame: Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h.). 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 NCT03712501, which also lists 3 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 14 May 2019.