The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test
1 other identifier
interventional
12
1 country
1
Brief Summary
The investigators hypothesize that cycling for 1 hour of exercise at 65% peak oxygen consumption (VO2peak) after sitting \>13 hr/day (SIT+EX) will not be different in postprandial plasma insulin responses compared to the control of only sitting (SIT). Furthermore, the investigators hypothesize that the SIT and SIT+EX groups will have a less favorble insulin response compared to the physically active group after performing the same 1-hour exercise bout (ACTIVE+EX).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2019
CompletedFirst Submitted
Initial submission to the registry
September 24, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2020
CompletedDecember 11, 2019
December 1, 2019
9 months
September 24, 2019
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity
The investigators will measure glucose and insulin levels from data collected during the oral glucose tolerance test.
Up to 4 weeks after data completion
Study Arms (3)
SIT
EXPERIMENTALSubject will be asked to take \<3,000 steps for two intervention days prior to an oral glucose tolerance test on the third day.
SIT+EX
EXPERIMENTALSubject will be asked to take \<3,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day.
ACTIVE+EX
EXPERIMENTALSubject will be asked to take \>10,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day.
Interventions
For the SIT and SIT+EX conditions, the subject will be asked to take \<3,000 steps. This is meant to achieve \~12-13 hours of sitting per day, are the investigators are measuring the effect of inactivity and exercise on insulin sensitivity.
For the ACTIVE+EX condition, the subject will be asked to take \>10,000 steps for the two intervention days. This is meant to simulate an active lifestyle.
The SIT+EX and ACTIVE+EX conditions will include an exercise bout on the evening of the second intervention day, and have the oral glucose tolerance test the next morning.
Eligibility Criteria
You may qualify if:
- Healthy, untrained/recreationally active men and women.
- Women must not be pregnant or post-menopausal.
You may not qualify if:
- Heart problems or coronary artery disease
- Hypertension
- Lung or respiratory problems
- Chest pain, fainting, or heart palpitations during exercise, or told to give up sports because of health problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas at Austin
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Dial
University of Texas at Austin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Graduate Student
Study Record Dates
First Submitted
September 24, 2019
First Posted
December 11, 2019
Study Start
September 23, 2019
Primary Completion
June 30, 2020
Study Completion
September 23, 2020
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share