NCT04195165

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

September 24, 2019

Last Update Submit

December 9, 2019

Conditions

Keywords

glucose toleranceexerciseinsulin sensitivity

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

EXPERIMENTAL

Subject will be asked to take \<3,000 steps for two intervention days prior to an oral glucose tolerance test on the third day.

Behavioral: SIT

SIT+EX

EXPERIMENTAL

Subject 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.

Behavioral: SITBehavioral: EX

ACTIVE+EX

EXPERIMENTAL

Subject 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.

Behavioral: ACTIVEBehavioral: EX

Interventions

SITBEHAVIORAL

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.

SITSIT+EX
ACTIVEBEHAVIORAL

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.

ACTIVE+EX
EXBEHAVIORAL

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.

Also known as: Exercise
ACTIVE+EXSIT+EX

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorInsulin ResistanceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael B Dial

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

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

Locations