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Influence of Prior Walking on Postprandial Metabolism and Endothelial Function.

Primary Purpose

Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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);
  • 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.

Sites / Locations

  • National Centre for Sport and Exercise Medicine, Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

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.

Participants will rest on day 1. Participants will return the following day where they will consume a high fat breakfast and lunch.

Outcomes

Primary Outcome Measures

Triacylglycerol
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.

Secondary Outcome Measures

Endothelial function
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Blood pressure
Changes in blood pressure (systolic and diastolic).
Glucose
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Total cholesterol
Fasting plasma total cholesterol on day 1 and day 2 of both trials.
Insulin
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
High-density lipoprotein cholesterol
Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
Low-density lipoprotein cholesterol
Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.
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.
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.
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.
Peroxiredoxin-4
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Superoxide dismutase 3
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials

Full Information

First Posted
October 17, 2018
Last Updated
May 13, 2019
Sponsor
Loughborough University
Collaborators
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT03712501
Brief Title
Influence of Prior Walking on Postprandial Metabolism and Endothelial Function.
Official Title
Influence of Prior Walking on Postprandial Metabolism and Endothelial Function in South Asian vs White European Women.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
University Hospitals, Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction, Insulin Resistance, Oxidative Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will rest on day 1. Participants will return the following day where they will consume a high fat breakfast and lunch.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
A 60 minute walk at 60% maximal oxygen uptake.
Primary Outcome Measure Information:
Title
Triacylglycerol
Description
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
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.
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Time Frame
Day 1 fasting and 8.75h. Day 2 fasting and 3.5h.
Title
Blood pressure
Description
Changes in blood pressure (systolic and diastolic).
Time Frame
Day 1 fasting. Day 2 fasting and 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h and 9h.
Title
Glucose
Description
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
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
Title
Total cholesterol
Description
Fasting plasma total cholesterol on day 1 and day 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Insulin
Description
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h, 8h.
Title
High-density lipoprotein cholesterol
Description
Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Low-density lipoprotein cholesterol
Description
Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Non-esterified fatty acids
Description
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.
Time Frame
Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h and 9h.
Title
Interleukin-6
Description
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Title
C-Reactive protein
Description
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Title
Peroxiredoxin-4
Description
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.
Title
Superoxide dismutase 3
Description
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Time Frame
Day 1 fasting. Day 2 fasting, 3h, 6h and 8h.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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); 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Roberts
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Centre for Sport and Exercise Medicine, Loughborough University
City
Loughborough
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymised individual participant data for all primary and secondary outcome measures will be made available.
Citations:
PubMed Identifier
26438068
Citation
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.
Results Reference
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PubMed Identifier
23470315
Citation
Arjunan 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.
Results Reference
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Influence of Prior Walking on Postprandial Metabolism and Endothelial Function.

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