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Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults (B-WELL)

Primary Purpose

Metabolic Syndrome, Diabetes, Aging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
US
IW
CW
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Sedentary behavior, physical activity, older adults

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 60-85 yr • BMI 25-35 kg.m-2
  • Non-exercisers (<150 m/wk of moderate intensity exercise)
  • Sedentary (>60% of waking day sedentary)
  • Able to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph

Exclusion Criteria:

  • Self-reported acute or chronic disease (e.g. diabetes, heart disease, thyroid disease)
  • Fasting plasma glucose ≥ 126 mg/dl - participants will not be excluded if they an abnormal post prandial glucose levels (e.g. glucose ≥ 200 mg/dl) following the MTT's.
  • Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
  • Females who previously used (> 6 months) or are currently using any formulation of estrogen-based hormone therapy (e.g., oral Premarin, transdermal 17-estradiol, selective estrogen receptor modulators).
  • Resting diastolic blood pressure > 100 mm mercury or resting systolic blood pressure > 160 mm mercury
  • Contra-indications to exercise (e.g. orthopedic limitations)
  • Unable to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph

Sites / Locations

  • University of Colorado Denver Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

US/IW/CW

IW/US/CW

IW/CW/US

CW/IW/US

CW/US/IW

US/CW/IW

Arm Description

This is a 3 arm crossover design. Arm US/IW/CW corresponds to the group of participants randomized to uninterrupted sitting (US) first, then Intermittent Walking (IW) and then continuous walk (CW).

This is a 3 arm crossover design. Arm IW/US/CW corresponds to the group of participants randomized to Intermittent Walking (IW) first, then uninterrupted sitting (US), and then continuous walk (CW).

This is a 3 arm crossover design. Arm IW/CW/US corresponds to the group of participants randomized to Intermittent Walking (IW) first, then Continuous Walk (CW) and then Uninterrupted Sitting (US).

This is a 3 arm crossover design. Arm CW/IW/US corresponds to the group of participants randomized to Continuous Walk (CW) first, then Intermittent Walking (IW) and then Uninterrupted Sitting (US).

This is a 3 arm crossover design. Arm CW/IW/US corresponds to the group of participants randomized to Continuous Walk (CW) first, then Uninterrupted Sitting (US), and then Intermittent Walking (IW).

This is a 3 arm crossover design. Arm US/CW/IW corresponds to the group of participants randomized to Uninterrupted Sitting (US) first, then Continuous Walk (CW), and then Intermittent Walking (IW).

Outcomes

Primary Outcome Measures

Incremental area under the glucose curve in response to meal tolerance test (MTT)
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Glucose area under the curve (AUC) is compared between conditions.
Area under the insulin curve in response to meal tolerance test
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Insulin AUC is compared between conditions.

Secondary Outcome Measures

Postprandial glycemia in response to meal tolerance test
Postprandial glycemia (PPG) will be measured using a continuous glucose monitor. Peak PPG, rate of change in peak PPG and duration of hyperglycemia will be calculated. Meal tolerance test will be performed during uninterrupted sitting condition and during intermittent walking condition. PPG will be compared between conditions.
Insulin sensitivity
Insulin sensitivity will be measured using a hyperinsulinemic euglycemic clamp. IS will be assessed after intermittent walking condition and after continuous walk condition. IS will be compared between conditions.
24-hr Fat Oxidation
Fat oxidation will be measured in a whole room indirect calorimeter during the intermittent walking condition and during the continuous walk condition. Fat oxidation will be compared between conditions.
24-hour Glycemic variability
Glycemic variability will be measured using a continuous glucose monitor during the intermittent walking condition and during the continuous walk condition. Glycemic variability will be compared between conditions.

Full Information

First Posted
November 21, 2013
Last Updated
August 20, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01997021
Brief Title
Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults
Acronym
B-WELL
Official Title
Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Increasing physical activity in older adults has important implications for treating obesity related metabolic conditions, however the interaction of aging- and obesity-related declines in physical function may make adding structured exercise particularly challenging for this group. Given these challenges, an alternative prescription to traditional structured exercise, may be short bouts of intermittent walking scattered throughout the day - this may be an effective strategy to increase physical activity, reduce sedentary behavior, and improve glycemic control in overweight/obese older adults. The purpose of this project is to determine how interrupting sedentary time with short bouts of moderate intensity walking affects important metabolic outcomes in older, overweight adults. It would also be of interest to compare the effects of short, frequent interruptions in sedentary behavior to a traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims of the proposed research are to 1) Determine the effect of performing short bouts of moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m walk (CW)) on metabolism. The investigators hypothesize that interrupting sedentary time with intermittent walking will improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as effective at improving metabolism as a single continuous 30 min walk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes, Aging
Keywords
Sedentary behavior, physical activity, older adults

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
US/IW/CW
Arm Type
Experimental
Arm Description
This is a 3 arm crossover design. Arm US/IW/CW corresponds to the group of participants randomized to uninterrupted sitting (US) first, then Intermittent Walking (IW) and then continuous walk (CW).
Arm Title
IW/US/CW
Arm Type
Experimental
Arm Description
This is a 3 arm crossover design. Arm IW/US/CW corresponds to the group of participants randomized to Intermittent Walking (IW) first, then uninterrupted sitting (US), and then continuous walk (CW).
Arm Title
IW/CW/US
Arm Type
Experimental
Arm Description
This is a 3 arm crossover design. Arm IW/CW/US corresponds to the group of participants randomized to Intermittent Walking (IW) first, then Continuous Walk (CW) and then Uninterrupted Sitting (US).
Arm Title
CW/IW/US
Arm Type
Experimental
Arm Description
This is a 3 arm crossover design. Arm CW/IW/US corresponds to the group of participants randomized to Continuous Walk (CW) first, then Intermittent Walking (IW) and then Uninterrupted Sitting (US).
Arm Title
CW/US/IW
Arm Type
Experimental
Arm Description
This is a 3 arm crossover design. Arm CW/IW/US corresponds to the group of participants randomized to Continuous Walk (CW) first, then Uninterrupted Sitting (US), and then Intermittent Walking (IW).
Arm Title
US/CW/IW
Arm Type
Experimental
Arm Description
This is a 3 arm crossover design. Arm US/CW/IW corresponds to the group of participants randomized to Uninterrupted Sitting (US) first, then Continuous Walk (CW), and then Intermittent Walking (IW).
Intervention Type
Other
Intervention Name(s)
US
Other Intervention Name(s)
Uninterrupted sitting
Intervention Description
US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
Intervention Type
Other
Intervention Name(s)
IW
Other Intervention Name(s)
Intermittent Walking
Intervention Description
IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
Intervention Type
Other
Intervention Name(s)
CW
Other Intervention Name(s)
Continuous Walking
Intervention Description
CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
Primary Outcome Measure Information:
Title
Incremental area under the glucose curve in response to meal tolerance test (MTT)
Description
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Glucose area under the curve (AUC) is compared between conditions.
Time Frame
Hourly for 5 hours after meal is consumed
Title
Area under the insulin curve in response to meal tolerance test
Description
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Insulin AUC is compared between conditions.
Time Frame
Hourly for 5 hours after meal is consumed
Secondary Outcome Measure Information:
Title
Postprandial glycemia in response to meal tolerance test
Description
Postprandial glycemia (PPG) will be measured using a continuous glucose monitor. Peak PPG, rate of change in peak PPG and duration of hyperglycemia will be calculated. Meal tolerance test will be performed during uninterrupted sitting condition and during intermittent walking condition. PPG will be compared between conditions.
Time Frame
Continuously for 5 hours after meal is consumed
Title
Insulin sensitivity
Description
Insulin sensitivity will be measured using a hyperinsulinemic euglycemic clamp. IS will be assessed after intermittent walking condition and after continuous walk condition. IS will be compared between conditions.
Time Frame
Immediately post 24 hr intermittent walking and continuous walking conditions
Title
24-hr Fat Oxidation
Description
Fat oxidation will be measured in a whole room indirect calorimeter during the intermittent walking condition and during the continuous walk condition. Fat oxidation will be compared between conditions.
Time Frame
Continuously during 24 hr intermittent walking and continuous walking conditions
Title
24-hour Glycemic variability
Description
Glycemic variability will be measured using a continuous glucose monitor during the intermittent walking condition and during the continuous walk condition. Glycemic variability will be compared between conditions.
Time Frame
Continuously during 24 hr intermittent walking and continuous walking conditions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 60-85 yr • BMI 25-35 kg.m-2 Non-exercisers (<150 m/wk of moderate intensity exercise) Sedentary (>60% of waking day sedentary) Able to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph Exclusion Criteria: Self-reported acute or chronic disease (e.g. diabetes, heart disease, thyroid disease) Fasting plasma glucose ≥ 126 mg/dl - participants will not be excluded if they an abnormal post prandial glucose levels (e.g. glucose ≥ 200 mg/dl) following the MTT's. Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months Females who previously used (> 6 months) or are currently using any formulation of estrogen-based hormone therapy (e.g., oral Premarin, transdermal 17-estradiol, selective estrogen receptor modulators). Resting diastolic blood pressure > 100 mm mercury or resting systolic blood pressure > 160 mm mercury Contra-indications to exercise (e.g. orthopedic limitations) Unable to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Lyden, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ed Melanson, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults

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