Metabolic SyndromeNCT01700530
Exercise, Statins, and the Metabolic Syndrome
A study testing Statin, Exercise only and Statins + Exercise in people with Metabolic Syndrome and Obese, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. We also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness. Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obese, Sedentary
- What is being tested?
- Statin, Exercise only and Statins + Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary metabolic syndrome subjects will be 25-59 y of age
- overweight to Class I or II obese (BMI 25-39 kg/m2) men and women
- 2 of 4 other characteristics of the metabolic syndrome including fasting glucose of 100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, HDL-C concentrations less than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmHG
- Women must be taking birth control or be postmenopausal.
Who cannot join
- Diagnosed cardiovascular disease or diabetes or disease
- Symptoms that could alter their ability to perform exercise
- Fasting blood glucose of greater than 126 mg/dl
- Smoking
- Taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidenediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity.
- Women who are pregnant or plan to become pregnant during the duration of the study
Show all 9Show fewer
- Individuals exercising regularly (more than one 30 min session per week)
- Individuals with an orthopedic limitations for walking.
- Report any allergies to the medications (statins, lidocaine)
Trial locations and contacts
1 site in 1 country.
About this study
Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. We also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness.
Read the detailed description
OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.
BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle changes, including exercise, to reduce cardiovascular disease risk in patients with the metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired mitochondrial function, but it is unclear whether statin use alters adaptations to exercise training.
METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40 mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity).
- Conditions
- Metabolic Syndrome, Obese, Sedentary
- Being tested
- Statin, Exercise only, Statins + Exercise
- Keywords
- mitochondria, fitness, statins, cholesterol, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called simvastatin
Statins (40mg/day)for 12 weeks
Exercise onlyOther
Also called Physical activity
12 weeks of exercise training (5 days a week for 45-50 min a session)
Statins + ExerciseOther
Also called Statins + Physical Activity
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | Statins (40mg/day)for an average of 12 weeks Receives: Drug: Statin |
| Exercise only | Experimental | 12 weeks of exercise training (5 days a week for 45-50 min a session) Receives: Other: Exercise only |
| Statins + Exercise | Active comparator | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks Receives: Other: Statins + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change in VO2max (Fitness)
% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max
Measured: Change from Baseline to 12 weeks
Secondary outcomes (1)
Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)
% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startMay 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia, American Heart Association
- Responsible party
- Sponsor
- Investigators
- John P Thyfault, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700530
- Sponsor's protocol ID
- 09CRP2260136
- Status last verified
- Jan 2016
- First submitted
- 26 Sep 2012
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.
PubMed 23583255
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise, Statins, and the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01700530
- Acronym / sponsor ID
- 09CRP2260136
- Conditions
- Metabolic Syndrome, Obese, Sedentary
- Keywords
- mitochondria, fitness, statins, cholesterol, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia, American Heart Association
- Study start
- May 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. We also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness.
Detailed description
OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.
BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle changes, including exercise, to reduce cardiovascular disease risk in patients with the metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired mitochondrial function, but it is unclear whether statin use alters adaptations to exercise training.
METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40 mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: StatinStatins (40mg/day)for an average of 12 weeks |
| Exercise only | Experimental | Other: Exercise only12 weeks of exercise training (5 days a week for 45-50 min a session) |
| Statins + Exercise | Active comparator | Other: Statins + ExerciseStatins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sedentary metabolic syndrome subjects will be 25-59 y of age
- overweight to Class I or II obese (BMI 25-39 kg/m2) men and women
- 2 of 4 other characteristics of the metabolic syndrome including fasting glucose of 100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, HDL-C concentrations less than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmHG
- Women must be taking birth control or be postmenopausal.
Key exclusion criteria (9 listed)
- Diagnosed cardiovascular disease or diabetes or disease
- Symptoms that could alter their ability to perform exercise
- Fasting blood glucose of greater than 126 mg/dl
- Smoking
- Taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidenediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity.
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 |
|---|---|---|
| StatinAlso: simvastatinStatins (40mg/day)for 12 weeks | Drug | Statin |
| Exercise onlyAlso: Physical activity12 weeks of exercise training (5 days a week for 45-50 min a session) | Other | Exercise only |
| Statins + ExerciseAlso: Statins + Physical ActivityStatins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks | Other | Statins + Exercise |
Primary outcome
% Change in VO2max (Fitness)
Time frame: Change from Baseline to 12 weeks
% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max
1 secondary outcome
Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23583255Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.
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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.
John P Thyfault, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statin, Exercise only and Statins + Exercise in people with Metabolic Syndrome and Obese, run by University of Kansas Medical Center 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 9 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 5 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
% Change in VO2max (Fitness) (time frame: Change from Baseline to 12 weeks). 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 NCT01700530, which also lists 1 linked publication.
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 5 Feb 2016.