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Effects of Standing on Glycemia in Prediabetic Adults

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01884792
First received: June 19, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Prediabetes
Other: Sitting OGTT
Other: Standing OGTT
Other: Sitting CGM
Other: Standing CGM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Blood sugar area under the curve [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The area under the curve following the 2 hour blood sugar tests.


Secondary Outcome Measures:
  • Accelerometer counts [ Time Frame: 4 hours and 2 5 day periods ] [ Designated as safety issue: No ]
    Accelerometer counts in the 4 testing conditions.


Enrollment: 20
Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Sitting OGTT Other: Standing OGTT
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.
Other: Sitting OGTT Other: Standing OGTT
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.
Other: Sitting CGM Other: Standing CGM
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.
Other: Sitting CGM Other: Standing CGM

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884792

Locations
United States, Minnesota
Department of Human Services
St. Paul, Minnesota, United States, 55155
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Mayo Clinic
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01884792     History of Changes
Other Study ID Numbers: 1208M18741
Study First Received: June 19, 2013
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
prediabetes
physical inactivity
sedentary
standing

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014