Metabolic SyndromeB-WELLNCT01997021

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

A study testing US, IW and CW in people with Metabolic Syndrome and Diabetes, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Metabolic Syndrome, Diabetes, Aging
What is being tested?: US, IW and CW
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Nov 2013to 31 Dec 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Conditions: Metabolic Syndrome, Diabetes, Aging
Being tested: US, IW, CW
Keywords: Sedentary behavior, physical activity, older adults
Medical subject headings: Metabolic Syndrome, Diabetes Mellitus, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

USOther
Also called Uninterrupted sitting
US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
IWOther
Also called Intermittent Walking
IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
CWOther
Also called Continuous Walking
CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.

Study groups in NCT01997021
Study group	Role	What they receive
US/IW/CW	Experimental	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). Receives: Other: US; Other: IW; Other: CW
IW/US/CW	Experimental	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). Receives: Other: US; Other: IW; Other: CW
IW/CW/US	Experimental	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). Receives: Other: US; Other: IW; Other: CW
CW/IW/US	Experimental	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). Receives: Other: US; Other: IW; Other: CW
CW/US/IW	Experimental	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). Receives: Other: US; Other: IW; Other: CW
US/CW/IW	Experimental	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). Receives: Other: US; Other: IW; Other: CW

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Hourly for 5 hours after meal is consumed
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.
Measured: Hourly for 5 hours after meal is consumed

Secondary outcomes (4)

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.
Measured: Continuously for 5 hours after meal is consumed
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.
Measured: Immediately post 24 hr intermittent walking and continuous walking 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.
Measured: Continuously during 24 hr intermittent walking and continuous walking 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.
Measured: Continuously during 24 hr intermittent walking and continuous walking conditions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201331 Dec 2014

First posted27 Nov 2013 (estimated)
Study startNov 2013
Primary completion31 Dec 2014
Study completion31 Dec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01997021
Sponsor's protocol ID: 13-2594
Acronym: B-WELL
Status last verified: Aug 2021
First submitted: 21 Nov 2013
Last updated: 24 Aug 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults
ClinicalTrials.gov ID: NCT01997021
Acronym / sponsor ID: B-WELL / 13-2594
Conditions: Metabolic Syndrome, Diabetes, Aging
Keywords: Sedentary behavior, physical activity, older adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Nov 2013
Primary completion: 31 Dec 2014 (actual)
Study completion: 31 Dec 2014 (actual)
First posted: 27 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
US/IW/CW	Experimental	Other: US, Other: IW, Other: CWThis 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).
IW/US/CW	Experimental	Other: US, Other: IW, Other: CWThis 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).
IW/CW/US	Experimental	Other: US, Other: IW, Other: CWThis 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).
CW/IW/US	Experimental	Other: US, Other: IW, Other: CWThis 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).
CW/US/IW	Experimental	Other: US, Other: IW, Other: CWThis 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).
US/CW/IW	Experimental	Other: US, Other: IW, Other: CWThis 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).

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
USAlso: Uninterrupted sittingUS is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.	Other	CW/IW/US, CW/US/IW, IW/CW/US, IW/US/CW, US/CW/IW, US/IW/CW
IWAlso: Intermittent WalkingIW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.	Other	CW/IW/US, CW/US/IW, IW/CW/US, IW/US/CW, US/CW/IW, US/IW/CW
CWAlso: Continuous WalkingCW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.	Other	CW/IW/US, CW/US/IW, IW/CW/US, IW/US/CW, US/CW/IW, US/IW/CW

Primary outcome

Incremental area under the glucose curve in response to meal tolerance test (MTT)
Time frame: Hourly for 5 hours after meal is consumed
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
Time frame: Hourly for 5 hours after meal is consumed
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Insulin AUC is compared between conditions.

4 secondary outcomes

Postprandial glycemia in response to meal tolerance test
Time frame: Continuously for 5 hours after meal is consumed
Insulin sensitivity
Time frame: Immediately post 24 hr intermittent walking and continuous walking conditions
24-hr Fat Oxidation
Time frame: Continuously during 24 hr intermittent walking and continuous walking conditions
24-hour Glycemic variability
Time frame: Continuously during 24 hr intermittent walking and continuous walking conditions

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kate Lyden, PhD principal investigator

University of Colorado, Denver

Ed Melanson, PhD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing US, IW and CW in people with Metabolic Syndrome and Diabetes, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental area under the glucose curve in response to meal tolerance test (MTT) (time frame: Hourly for 5 hours after meal is consumed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01997021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.