- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01884792
Effects of Standing on Glycemia in Prediabetic Adults
September 12, 2014 updated by: University of Minnesota
Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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St. Paul, Minnesota, United States, 55155
- Department of Human Services
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fasting blood glucose >100 mg/dl
- Employed full-time working at least 35 hours/week
- Able to safely begin a light physical activity program
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Sitting Oral Glucose Tolerance Test
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.
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EXPERIMENTAL: Standing Oral Glucose Tolerance Test
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.
|
|
PLACEBO_COMPARATOR: Sitting Continuous Glucose Monitor
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.
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EXPERIMENTAL: Standing Continuous Glucose Monitor
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood sugar area under the curve
Time Frame: 2 hours
|
The area under the curve following the 2 hour blood sugar tests.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accelerometer counts
Time Frame: 4 hours and 2 5 day periods
|
Accelerometer counts in the 4 testing conditions.
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4 hours and 2 5 day periods
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
September 1, 2013
Study Registration Dates
First Submitted
June 19, 2013
First Submitted That Met QC Criteria
June 21, 2013
First Posted (ESTIMATE)
June 24, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2014
Last Update Submitted That Met QC Criteria
September 12, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1208M18741
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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