Insulin ResistanceNCT00687128
Exercise Dose-Response on Features of the Metabolic Syndrome
A study testing Low-intensity treadmill exercise, Moderate-intensity treadmill exercise and Non-aerobic stretching exercise in people with Insulin Resistance and Metabolic Syndrome, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
This study investigates the degree of improvement in insulin resistance and features of the metabolic syndrome in non-diabetic overweight or obese subjects after training in a low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated exercise behavior after the assigned exercise… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome, Obesity
- What is being tested?
- Low-intensity treadmill exercise, Moderate-intensity treadmill exercise and Non-aerobic stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Apr 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females, age 18-60
- At least 2 of the 5 components of the NCEP definition of the metabolic syndrome, provided that either the triglyceride or waist circumference criteria are met
- Body mass index of 25-45 kg/m2
- Subjects not currently following a regular exercise program nor an optimal diet, and who self-report their activity level as sedentary
- Able to understand and sign the informed consent form, follow the instructions given in the study, attend all necessary clinic visits, and undergo all required study procedures
Who cannot join
- Past or current diabetes mellitus
- Significant concurrent medical illnesses (chronic liver or renal disease, malignancies, recent or chronic infections including HIV, surgeries or other hospitalizations within four weeks prior to screening), uncontrolled hypertension (BP >160/90 mm Hg), or abnormal TSH on screening.
- Conditions that may contraindicate physical activity (clinically significant cardiac, pulmonary, orthopedic, rheumatological or neurological diseases)
- Cardiovascular disease not controlled with medical therapy, or invasive vascular procedures within six months prior to screening
- Subjects found on resting EKG or stress testing to have underlying cardiac abnormalities
- Perimenopausal women who are experiencing irregular menses
Show all 13Show fewer
- Pregnant or lactating women
- Subjects who may have limited exercise tolerance because of treatment with β-adrenergic blockade agents, at least until agents of alternate drug classes can be substituted
- Subjects with concurrent endocrinopathies
- Subjects receiving concurrent treatment with metformin, thiazolidinediones, systemic glucocorticoids, or any weight loss agents
- Subjects who expect to require medications during the course of the study that may affect their metabolic profile, including systemic glucocorticoids and hormone replacement therapies
- Subjects who cannot complete the stress test due to physical limitations
- Any other factors that, in the opinion of the investigators, may interfere with the safe conduct, the successful completion, or the quality of the data obtained from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome
This study investigates the degree of improvement in insulin resistance and features of the metabolic syndrome in non-diabetic overweight or obese subjects after training in a low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated exercise behavior after the assigned exercise program.
Read the detailed description
The proposed study is a randomized, open study comparing low-intensity and moderate-intensity aerobic exercise versus non-aerobic (stretching) exercise on direct measurements of insulin resistance and variables associated with the metabolic syndrome. This 6-month intervention will be followed by an additional 6-month follow-up period during which subjects will be encouraged to maintain their exercise regimen (along with their prescribed diet) but without scheduled supervision. Behavioral variables associated with adherence will be analyzed along with changes in the above physiological variables.
- Conditions
- Insulin Resistance, Metabolic Syndrome, Obesity
- Being tested
- Low-intensity treadmill exercise, Moderate-intensity treadmill exercise, Non-aerobic stretching exercise
- Keywords
- Insulin resistance, Metabolic syndrome, Aerobic exercise, Exercise behavior
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity treadmill exerciseBehavioural
Also called "Casual" walking program
Treadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
Moderate-intensity treadmill exerciseBehavioural
Also called "Brisk" walking program
Treadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
Non-aerobic stretching exerciseBehavioural
Also called Non-aerobic control
Floor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low-intensity aerobic exercise Receives: Behavioral: Low-intensity treadmill exercise |
| 2 | Experimental | Moderate-intensity aerobic exercise Receives: Behavioral: Moderate-intensity treadmill exercise |
| 3 | Active comparator | Non-aerobic stretching exercise Receives: Behavioral: Non-aerobic stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity (clamp)
Measured: 6 months
Secondary outcomes (10)
Aerobic fitness (VO2Max, Anaerobic threshold, endurance time)
Measured: 6 and 12 months
Body mass index, waist circumference
Measured: 6 and 12 months
Fat mass, fat-free mass, lean body mass (DEXA)
Measured: 6 and 12 months
Blood pressure
Measured: 6 and 12 months
Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index
Measured: 6 and 12 months
Fasting lipid profile
Measured: 6 and 12 months
Apolipoprotein B
Measured: 6 and 12 months
Highly-sensitive C-reactive protein
Measured: 6 and 12 months
Exercise behavior questionnaire scores
Measured: 6 and 12 months
Any adverse events
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startOct 2004
- Primary completionSep 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Stanley Hsia, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687128
- Sponsor's protocol ID
- 04-10-788
- Other IDs
- U54RR014616
- Status last verified
- Feb 2012
- First submitted
- 27 May 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00687128
- Acronym / sponsor ID
- 04-10-788
- Conditions
- Insulin Resistance, Metabolic Syndrome, Obesity
- Keywords
- Insulin resistance, Metabolic syndrome, Aerobic exercise, Exercise behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Oct 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 May 2008 (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.
This study investigates the degree of improvement in insulin resistance and features of the metabolic syndrome in non-diabetic overweight or obese subjects after training in a low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated exercise behavior after the assigned exercise program.
Detailed description
The proposed study is a randomized, open study comparing low-intensity and moderate-intensity aerobic exercise versus non-aerobic (stretching) exercise on direct measurements of insulin resistance and variables associated with the metabolic syndrome. This 6-month intervention will be followed by an additional 6-month follow-up period during which subjects will be encouraged to maintain their exercise regimen (along with their prescribed diet) but without scheduled supervision. Behavioral variables associated with adherence will be analyzed along with changes in the above physiological variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Low-intensity treadmill exerciseLow-intensity aerobic exercise |
| 2 | Experimental | Behavioral: Moderate-intensity treadmill exerciseModerate-intensity aerobic exercise |
| 3 | Active comparator | Behavioral: Non-aerobic stretching exerciseNon-aerobic stretching exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females, age 18-60
- At least 2 of the 5 components of the NCEP definition of the metabolic syndrome, provided that either the triglyceride or waist circumference criteria are met
- Body mass index of 25-45 kg/m2
- Subjects not currently following a regular exercise program nor an optimal diet, and who self-report their activity level as sedentary
- Able to understand and sign the informed consent form, follow the instructions given in the study, attend all necessary clinic visits, and undergo all required study procedures
Key exclusion criteria (13 listed)
- Past or current diabetes mellitus
- Significant concurrent medical illnesses (chronic liver or renal disease, malignancies, recent or chronic infections including HIV, surgeries or other hospitalizations within four weeks prior to screening), uncontrolled hypertension (BP >160/90 mm Hg), or abnormal TSH on screening.
- Conditions that may contraindicate physical activity (clinically significant cardiac, pulmonary, orthopedic, rheumatological or neurological diseases)
- Cardiovascular disease not controlled with medical therapy, or invasive vascular procedures within six months prior to screening
- Subjects found on resting EKG or stress testing to have underlying cardiac abnormalities
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 |
|---|---|---|
| Low-intensity treadmill exerciseAlso: "Casual" walking programTreadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive. | Behavioural | 1 |
| Moderate-intensity treadmill exerciseAlso: "Brisk" walking programTreadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive. | Behavioural | 2 |
| Non-aerobic stretching exerciseAlso: Non-aerobic controlFloor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive. | Behavioural | 3 |
Primary outcome
Insulin sensitivity (clamp)
Time frame: 6 months
10 secondary outcomes
Aerobic fitness (VO2Max, Anaerobic threshold, endurance time)
Time frame: 6 and 12 months
Body mass index, waist circumference
Time frame: 6 and 12 months
Fat mass, fat-free mass, lean body mass (DEXA)
Time frame: 6 and 12 months
Blood pressure
Time frame: 6 and 12 months
Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index
Time frame: 6 and 12 months
Fasting lipid profile
Time frame: 6 and 12 months
Apolipoprotein B
Time frame: 6 and 12 months
Highly-sensitive C-reactive protein
Time frame: 6 and 12 months
Exercise behavior questionnaire scores
Time frame: 6 and 12 months
Any adverse events
Time frame: 6 and 12 months
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 28 Feb 2012.
- News item regarding the study. Click here for more information about the study: Dose-Response Effects of Aerobic Exercise on Insulin Resistance and the Metabolic SyndromeLink provided by the sponsor.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
Stanley Hsia, MD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity treadmill exercise, Moderate-intensity treadmill exercise and Non-aerobic stretching exercise in people with Insulin Resistance and Metabolic Syndrome, run by Charles Drew University of Medicine and Science 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 5 inclusion and 13 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 28 Feb 2012. 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?
Insulin sensitivity (clamp) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2012.