Endothelial DysfunctionNCT02919488
The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction
A study testing Exercise Condition in people with Endothelial Dysfunction, run by Texas Christian University at 1 site in United States.
Trial summary
The purpose of this study is to determine if postprandial (after a meal) endothelial (inner lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of exercise Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Exercise Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women
- Must be 45-70 years
Who cannot join
- Use of medications or supplements to lose weight
- Following a weight loss diet
- Smoking
- Heavy alcohol consumption
- Diabetes
- Heart disease
Show all 16Show fewer
- Stroke
- Liver disease
- Kidney disease
- Untreated thyroid disease
- Anemia
- Uncontrolled hypertension
- Pulmonary disease that prevents exercise
- Orthopedic problems that prevents exercise
- Arthritis problems that prevent exercise
- Musculoskeletal problems that prevent exercise.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if postprandial (after a meal) endothelial (inner lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of exercise
Read the detailed description
Endothelial dysfunction is due to an imbalance between vasodilating and vasoconstricting substances produced by the endothelium. An imbalance in these substances limits the ability of the blood vessel to relax in response to a shear stress stimulus. Endothelial dysfunction is a major risk factor for cardiovascular disease.
High-sugar intakes result in postprandial hyperglycemia and endothelial dysfunction. Exercise may attenuate the endothelial dysfunction induced by a high-sugar meal. There are only two studies that have examined the effect of exercise on endothelial dysfunction induced by high-sugar intake. Both studies found that a bout of aerobic exercise attenuated the impaired flow mediated dilation induced by high-sugar ingestion. Neither study measured important markers of endothelial dysfunction such as blood nitric oxide, endothelin I, and angiotensin II concentrations, however. In addition, whether the same results apply to older post-menopausal women is unknown. Understanding how acute exercise affects meal-induced endothelial dysfunction in older women is important given that age is related to endothelial dysfunction and cardiovascular disease.
- Conditions
- Endothelial Dysfunction
- Being tested
- Exercise Condition, Control Condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ConditionOther
A bout of exercise in the evening followed by high-sugar meal consumption the following morning
Control ConditionOther
Rest in the evening followed by high-sugar meal consumption the following morning
| Study group | Role | What they receive |
|---|---|---|
| Exercise Condition | Experimental | Not described Receives: Other: Exercise Condition |
| Control Condition | Active comparator | Not described Receives: Other: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brachial artery flow mediated dilation
Measured: 0, 60, 120, and 180 minutes
Secondary outcomes (7)
Change in blood nitric oxide concentration
Measured: 0, 60, 120, and 180 minutes
Change in blood endothelin-1concentration
Measured: 0, 60, 120, and 180 minutes
Change in blood angiotensin II concentration
Measured: 0, 60, 120, and 180 minutes
Change in blood glucose concentration
Measured: 0, 60, 120, and 180 minutes
Change in blood insulin concentration
Measured: 0, 60, 120, and 180 minutes
Change in blood lipoprotein particle numbers
Measured: 0, 60, 120, and 180 minutes
Change in blood lipid concentration
Measured: 0, 60, 120, and 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Shah, Texas Christian University
- Investigators
- Meena Shah, Ph.D., Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919488
- Sponsor's protocol ID
- CT2016MS2
- Status last verified
- Apr 2018
- First submitted
- 27 Sep 2016
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Deanfield J, Donald A, Ferri C, Giannattasio C, Halcox J, Halligan S, Lerman A, Mancia G, Oliver JJ, Pessina AC, Rizzoni D, Rossi GP, Salvetti A, Schiffrin EL, Taddei S, Webb DJ; Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. Endothelial function and dysfunction. Part I: Methodological issues for assessment in the different vascular beds: a statement by the Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005 Jan;23(1):7-17. doi: 10.1097/00004872-200501000-00004.
PubMed 15643116Widmer RJ, Lerman A. Endothelial dysfunction and cardiovascular disease. Glob Cardiol Sci Pract. 2014 Oct 16;2014(3):291-308. doi: 10.5339/gcsp.2014.43. eCollection 2014. No abstract available.
PubMed 25780786Loader J, Montero D, Lorenzen C, Watts R, Meziat C, Reboul C, Stewart S, Walther G. Acute Hyperglycemia Impairs Vascular Function in Healthy and Cardiometabolic Diseased Subjects: Systematic Review and Meta-Analysis. Arterioscler Thromb Vasc Biol. 2015 Sep;35(9):2060-72. doi: 10.1161/ATVBAHA.115.305530. Epub 2015 Jun 25.
PubMed 26112007Zhu W, Zhong C, Yu Y, Li K. Acute effects of hyperglycaemia with and without exercise on endothelial function in healthy young men. Eur J Appl Physiol. 2007 Apr;99(6):585-91. doi: 10.1007/s00421-006-0378-3. Epub 2007 Jan 6.
PubMed 17206439Weiss EP, Arif H, Villareal DT, Marzetti E, Holloszy JO. Endothelial function after high-sugar-food ingestion improves with endurance exercise performed on the previous day. Am J Clin Nutr. 2008 Jul;88(1):51-7. doi: 10.1093/ajcn/88.1.51.
PubMed 18614723Shah M, Gloeckner A, Bailey S, Adams-Huet B, Kreutzer A, Cheek D, Willis JL, Mitchell J. Effect of a late afternoon/early evening bout of aerobic exercise on postprandial lipid and lipoprotein particle responses to a high-sugar meal breakfast the following day in postmenopausal women: a randomized cross-over study. J Sports Sci. 2022 Jan;40(2):175-184. doi: 10.1080/02640414.2021.1982497. Epub 2021 Sep 27.
PubMed 34565292Shah M, Bailey S, Gloeckner A, Kreutzer A, Adams-Huet B, Cheek D, Mitchell J. Effect of acute exercise on postprandial endothelial function in postmenopausal women: a randomized cross-over study. J Investig Med. 2019 Aug;67(6):964-970. doi: 10.1136/jim-2019-000992. Epub 2019 Mar 5.
PubMed 30842213
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT02919488
- Acronym / sponsor ID
- CT2016MS2
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Sep 2016 (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 determine if postprandial (after a meal) endothelial (inner lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of exercise
Detailed description
Endothelial dysfunction is due to an imbalance between vasodilating and vasoconstricting substances produced by the endothelium. An imbalance in these substances limits the ability of the blood vessel to relax in response to a shear stress stimulus. Endothelial dysfunction is a major risk factor for cardiovascular disease.
High-sugar intakes result in postprandial hyperglycemia and endothelial dysfunction. Exercise may attenuate the endothelial dysfunction induced by a high-sugar meal. There are only two studies that have examined the effect of exercise on endothelial dysfunction induced by high-sugar intake. Both studies found that a bout of aerobic exercise attenuated the impaired flow mediated dilation induced by high-sugar ingestion. Neither study measured important markers of endothelial dysfunction such as blood nitric oxide, endothelin I, and angiotensin II concentrations, however. In addition, whether the same results apply to older post-menopausal women is unknown. Understanding how acute exercise affects meal-induced endothelial dysfunction in older women is important given that age is related to endothelial dysfunction and cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Condition | Experimental | Other: Exercise Condition |
| Control Condition | Active comparator | Other: Control Condition |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal women
- Must be 45-70 years
Key exclusion criteria (16 listed)
- Use of medications or supplements to lose weight
- Following a weight loss diet
- Smoking
- Heavy alcohol consumption
- Diabetes
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 |
|---|---|---|
| Exercise ConditionA bout of exercise in the evening followed by high-sugar meal consumption the following morning | Other | Exercise Condition |
| Control ConditionRest in the evening followed by high-sugar meal consumption the following morning | Other | Control Condition |
Primary outcome
Change in brachial artery flow mediated dilation
Time frame: 0, 60, 120, and 180 minutes
7 secondary outcomes
Change in blood nitric oxide concentration
Time frame: 0, 60, 120, and 180 minutes
Change in blood endothelin-1concentration
Time frame: 0, 60, 120, and 180 minutes
Change in blood angiotensin II concentration
Time frame: 0, 60, 120, and 180 minutes
Change in blood glucose concentration
Time frame: 0, 60, 120, and 180 minutes
Change in blood insulin concentration
Time frame: 0, 60, 120, and 180 minutes
Change in blood lipoprotein particle numbers
Time frame: 0, 60, 120, and 180 minutes
Change in blood lipid concentration
Time frame: 0, 60, 120, and 180 minutes
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 27 Apr 2018.
- Background: PubMed 15643116Deanfield J, Donald A, Ferri C, Giannattasio C, Halcox J, Halligan S, Lerman A, Mancia G, Oliver JJ, Pessina AC, Rizzoni D, Rossi GP, Salvetti A, Schiffrin EL, Taddei S, Webb DJ; Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. Endothelial function and dysfunction. Part I: Methodological issues for assessment in the different vascular beds: a statement by the Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005 Jan;23(1):7-17. doi: 10.1097/00004872-200501000-00004.
- Background: PubMed 25780786Widmer RJ, Lerman A. Endothelial dysfunction and cardiovascular disease. Glob Cardiol Sci Pract. 2014 Oct 16;2014(3):291-308. doi: 10.5339/gcsp.2014.43. eCollection 2014. No abstract available.
- Background: PubMed 26112007Loader J, Montero D, Lorenzen C, Watts R, Meziat C, Reboul C, Stewart S, Walther G. Acute Hyperglycemia Impairs Vascular Function in Healthy and Cardiometabolic Diseased Subjects: Systematic Review and Meta-Analysis. Arterioscler Thromb Vasc Biol. 2015 Sep;35(9):2060-72. doi: 10.1161/ATVBAHA.115.305530. Epub 2015 Jun 25.
- Background: PubMed 17206439Zhu W, Zhong C, Yu Y, Li K. Acute effects of hyperglycaemia with and without exercise on endothelial function in healthy young men. Eur J Appl Physiol. 2007 Apr;99(6):585-91. doi: 10.1007/s00421-006-0378-3. Epub 2007 Jan 6.
- Background: PubMed 18614723Weiss EP, Arif H, Villareal DT, Marzetti E, Holloszy JO. Endothelial function after high-sugar-food ingestion improves with endurance exercise performed on the previous day. Am J Clin Nutr. 2008 Jul;88(1):51-7. doi: 10.1093/ajcn/88.1.51.
- Derived from this study: PubMed 34565292Shah M, Gloeckner A, Bailey S, Adams-Huet B, Kreutzer A, Cheek D, Willis JL, Mitchell J. Effect of a late afternoon/early evening bout of aerobic exercise on postprandial lipid and lipoprotein particle responses to a high-sugar meal breakfast the following day in postmenopausal women: a randomized cross-over study. J Sports Sci. 2022 Jan;40(2):175-184. doi: 10.1080/02640414.2021.1982497. Epub 2021 Sep 27.
- Derived from this study: PubMed 30842213Shah M, Bailey S, Gloeckner A, Kreutzer A, Adams-Huet B, Cheek D, Mitchell J. Effect of acute exercise on postprandial endothelial function in postmenopausal women: a randomized cross-over study. J Investig Med. 2019 Aug;67(6):964-970. doi: 10.1136/jim-2019-000992. Epub 2019 Mar 5.
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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.
Meena Shah, Ph.D. principal investigator
Tzu Chi 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 Condition in people with Endothelial Dysfunction, run by Texas Christian University at 1 site in United States.
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 2 inclusion and 16 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 27 Apr 2018. 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 States. 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 brachial artery flow mediated dilation (time frame: 0, 60, 120, and 180 minutes). 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 NCT02919488, which also lists 7 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 27 Apr 2018.