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Effects of Standing on Glycemia in Prediabetic Adults

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sitting OGTT
Standing OGTT
Sitting CGM
Standing CGM
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prediabetes focused on measuring prediabetes, physical inactivity, sedentary, standing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Human Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Sitting Oral Glucose Tolerance Test

Standing Oral Glucose Tolerance Test

Sitting Continuous Glucose Monitor

Standing Continuous Glucose Monitor

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Accelerometer counts
Accelerometer counts in the 4 testing conditions.

Full Information

First Posted
June 19, 2013
Last Updated
September 12, 2014
Sponsor
University of Minnesota
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01884792
Brief Title
Effects of Standing on Glycemia in Prediabetic Adults
Official Title
Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
prediabetes, physical inactivity, sedentary, standing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitting Oral Glucose Tolerance Test
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standing Oral Glucose Tolerance Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Sitting Continuous Glucose Monitor
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standing Continuous Glucose Monitor
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sitting OGTT
Intervention Type
Other
Intervention Name(s)
Standing OGTT
Intervention Type
Other
Intervention Name(s)
Sitting CGM
Intervention Type
Other
Intervention Name(s)
Standing CGM
Primary Outcome Measure Information:
Title
Blood sugar area under the curve
Description
The area under the curve following the 2 hour blood sugar tests.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Accelerometer counts
Description
Accelerometer counts in the 4 testing conditions.
Time Frame
4 hours and 2 5 day periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Human Services
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55155
Country
United States

12. IPD Sharing Statement

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Effects of Standing on Glycemia in Prediabetic Adults

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