NCT03419754

Brief Summary

Prolonged sitting is a common behavior in contemporary humans. In epidemiological studies, increased sitting time has been associated with increased risk for cardiovascular disease and all-cause mortality. Recent research has also shown that interrupting sitting time with standing prevents the poorer glycemic control. However, studies are lacking which evaluate the impact of low intensity physical activity during prolonged sitting on vascular function. Whether low intensity physical activity can increase blood flow substantially and prevent impairment in vascular function and glycemic control is unknown. The purpose of the present study is to evaluate whether increased blood flow during sitting via low intensity physical activity (fidgetting) prevents the impairment in vascular function and poorer glycemic control associated with prolonged sitting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2018

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

January 20, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 20, 2018

Last Update Submit

March 23, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • glucose tolerance

    glucose area under the curve

    3 hr

  • flow mediated dilation

    flow

    every 30 min over 3 hr

Study Arms (2)

Glucose and Fidgetting

EXPERIMENTAL

75 g of glucose will be given at the beginning of the study day (days one with glucose+fidgeting )

Dietary Supplement: GlucoseBehavioral: Fidgetting

Fidgetting

PLACEBO COMPARATOR

Subjects will fidget their legs in an up and down motion for 2.5 min on and then 2.5 min off for the duration of the study.

Behavioral: Fidgetting

Interventions

GlucoseDIETARY_SUPPLEMENT

Glucose

Glucose and Fidgetting
FidgettingBEHAVIORAL

low intensity physical activity (fidgetting)

Also known as: low intensity physical activity
FidgettingGlucose and Fidgetting

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese males and females with metabolic syndrome, aged 20-60 years old.
  • According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met:
  • waist circumference over 40 inches (men) or 35 inches (women),
  • blood pressure over 130/85 mmHg,
  • fasting triglyceride (TG) level over 150 mg/dl,
  • fasting high-density lipoprotein (HDL) level less than 40 mg/dl (men) or 50 mg/dl (women)
  • fasting blood sugar over 100 mg/dl.

You may not qualify if:

  • they smoke
  • they have any known cardiovascular, pulmonary or metabolic disease
  • have type 2 diabetes
  • if good quality Doppler ultrasound image of their arteries cannot be obtained and/or evidence of plaque.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The subject will complete one intervention with consumption of 75 g of glucose with fidgeting and one intervention with no glucose consumption with fidgeting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 20, 2018

First Posted

February 5, 2018

Study Start

March 20, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations