NCT03089437

Brief Summary

The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

March 20, 2017

Last Update Submit

October 3, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Plasma Triglycerides

    The area under the curve for plasma triglycerides from hourly samples during a 6 hour high fat tolerance test

    6 hours

  • Plasma Insulin

    The area under the curve for plasma insulin from hourly samples during a 6 hour high fat tolerance test

    6 hours

  • Plasma Glucose

    The area under the curve for plasma glucose from hourly samples during a 6 hour high fat tolerance test

    6 hours

Study Arms (2)

Prolonged Standing

EXPERIMENTAL

Subject stand for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions.

Behavioral: Prolonged Standing

Prolonged Sitting

EXPERIMENTAL

Subject sit for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions.

Behavioral: Prolonged Sitting

Interventions

Subject will stand for 12 hours and undergo a high fat tolerance test the subsequent day

Prolonged Standing

Subject will sit for 12 hours and undergo a high fat tolerance test the subsequent day

Prolonged Sitting

Eligibility Criteria

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

You may not qualify if:

  • heart problems
  • coronary artery disease
  • hypertension
  • respiratory problems
  • musculoskeletal problems that prevent prolonged standing or sitting
  • obesity
  • susceptibility to fainting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin Human Performance Laboratory

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeAtherosclerosis

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

March 31, 2017

Primary Completion

August 11, 2017

Study Completion

August 11, 2018

Last Updated

October 4, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations