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Clinical Trials/NCT03511352
NCT03511352
Active, not recruiting
Not Applicable

Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)

University of California, San Diego1 site in 1 country78 target enrollmentMay 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedentary Lifestyle
Sponsor
University of California, San Diego
Enrollment
78
Locations
1
Primary Endpoint
Postprandial glucose
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time & Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.

Detailed Description

The specific aims of this protocol include: Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting. Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting. Aim 3. To explore the moderating effect of age.

Registry
clinicaltrials.gov
Start Date
May 8, 2018
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dorothy Sears

Associate Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • 55 years of age and above
  • any ethnicity or race
  • screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day \& engage in less than 20 minutes of moderate-to-vigorous physical activity (MVPA) per day
  • BMI 25 - 45 kg/m2
  • ambulatory
  • medically stable without any health conditions that would inhibit standing or PA;
  • able to give informed consent \& comply with study protocols;
  • able to read, communicate, and write fluently in English;
  • able to travel to study visits;
  • no menstruation for at least one year;

Exclusion Criteria

  • Mental state that would preclude complete understanding of the protocol or compliance;
  • type 1 diabetes;
  • type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants);
  • poorly controlled hypertension (Systolic Blood Pressure ≥165 or Diastolic Blood Pressure ≥100);
  • chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease),
  • anemia (hemoglobin ≤11g/dL);
  • personal or first-degree relative history of venous thrombosis;
  • weight instability in past 3 months (no more than 5% up or down);
  • regular use of vasodilator medication and high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (\>2X) in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke;
  • regular use of immunosuppressant or corticosteroid medication;

Outcomes

Primary Outcomes

Postprandial glucose

Time Frame: 5 hours

To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.

Insulin

Time Frame: 5 hours

To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.

Secondary Outcomes

  • Flow mediated dilation(5 hours)
  • Blood pressure(5 hours)

Study Sites (1)

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