NCT01884792

Brief Summary

The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.

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

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

June 19, 2013

Last Update Submit

September 12, 2014

Conditions

Keywords

prediabetesphysical inactivitysedentarystanding

Outcome Measures

Primary Outcomes (1)

  • Blood sugar area under the curve

    The area under the curve following the 2 hour blood sugar tests.

    2 hours

Secondary Outcomes (1)

  • Accelerometer counts

    4 hours and 2 5 day periods

Study Arms (4)

Sitting Oral Glucose Tolerance Test

PLACEBO COMPARATOR

An OGTT is performed while the subject sits at their desk for the entire 2-hour period. 5 blood sugar measurements are taken and a 75g dextrose beverage is consumed following the first, baseline blood sugar reading. The blood sugar is then measured every 30 minutes up to 120 min.

Other: Sitting OGTTOther: Standing OGTT

Standing Oral Glucose Tolerance Test

EXPERIMENTAL

The participant stands at their desk for the duration of the 2-hour blood sugar test. The same procedure is performed as in the sitting condition.

Other: Sitting OGTTOther: Standing OGTT

Sitting Continuous Glucose Monitor

PLACEBO COMPARATOR

A continuous blood glucose monitor is worn for 5 days while at work. In the sitting condition the participant only sits at their desk for the duration of the week. Blood sugar is monitored 4 times per day to calibrate the CGM and an accelerometer is worn to track physical activity.

Other: Sitting CGMOther: Standing CGM

Standing Continuous Glucose Monitor

EXPERIMENTAL

Participants are instructed to stand intermittently for at least half of their work day during this 5 day period. Blood sugar is monitored and physical activity is tracked with an accelerometer.

Other: Sitting CGMOther: Standing CGM

Interventions

Sitting Oral Glucose Tolerance TestStanding Oral Glucose Tolerance Test
Sitting Oral Glucose Tolerance TestStanding Oral Glucose Tolerance Test
Sitting Continuous Glucose MonitorStanding Continuous Glucose Monitor
Sitting Continuous Glucose MonitorStanding Continuous Glucose Monitor

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting blood glucose \>100 mg/dl
  • Employed full-time working at least 35 hours/week
  • Able to safely begin a light physical activity program

You may not qualify if:

  • Heart disease
  • Renal disease
  • Peripheral neuropathy
  • Retinopathy
  • PAD
  • Lower limb amputation
  • pregnancy
  • active substance abuse
  • current smoker
  • psychiatric disorder
  • severe visual impairment
  • immune-compromised individuals,
  • enrollment in a physical activity study
  • use of insulin or an insulin pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Services

Saint Paul, Minnesota, 55155, United States

Location

MeSH Terms

Conditions

Prediabetic StateSedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 24, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations