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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02919488
Other study ID # CT2016MS2
Secondary ID
Status Completed
Phase N/A
First received September 27, 2016
Last updated April 25, 2018
Start date November 2016
Est. completion date December 2017

Study information

Verified date April 2018
Source Texas Christian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria:

- Post-menopausal women

- Must be 45-70 years

Exclusion Criteria:

- Use of medications or supplements to lose weight

- Following a weight loss diet

- Smoking

- Heavy alcohol consumption

- Diabetes

- Heart disease

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise Condition
A bout of exercise in the evening followed by high-sugar meal consumption the following morning
Control Condition
Rest in the evening followed by high-sugar meal consumption the following morning

Locations

Country Name City State
United States Texas Christian University Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

Loader J, Montero D, Lorenzen C, Watts R, Méziat 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. Review. — View Citation

Weiss 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. — View Citation

Widmer 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. Review. — View Citation

Zhu 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. Epub 2007 Jan 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in brachial artery flow mediated dilation 0, 60, 120, and 180 minutes
Secondary Change in blood nitric oxide concentration 0, 60, 120, and 180 minutes
Secondary Change in blood endothelin-1concentration 0, 60, 120, and 180 minutes
Secondary Change in blood angiotensin II concentration 0, 60, 120, and 180 minutes
Secondary Change in blood glucose concentration 0, 60, 120, and 180 minutes
Secondary Change in blood insulin concentration 0, 60, 120, and 180 minutes
Secondary Change in blood lipoprotein particle numbers 0, 60, 120, and 180 minutes
Secondary Change in blood lipid concentration 0, 60, 120, and 180 minutes
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