Exercise, Statins, and the Metabolic Syndrome
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
| Condition | Intervention |
|---|---|
| Metabolic Syndrome Obese Sedentary | Drug: Statin Other: Exercise only Other: Statins + Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Exercise, Statins, and the Metabolic Syndrome |
- % 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
- Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity) [ Time Frame: 12 weeks ]% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention
| Enrollment: | 121 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Statin
Statins (40mg/day)for an average of 12 weeks
|
Drug: Statin
Statins (40mg/day)for 12 weeks
Other Name: simvastatin
|
|
Experimental: Exercise only
12 weeks of exercise training (5 days a week for 45-50 min a session)
|
Other: Exercise only
12 weeks of exercise training (5 days a week for 45-50 min a session)
Other Name: Physical activity
|
|
Active Comparator: Statins + Exercise
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
|
Other: Statins + Exercise
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
Other Name: Statins + Physical Activity
|
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).
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 25 Years to 59 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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)
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700530
| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65211 | |
| Principal Investigator: | John P Thyfault, PhD | University of Missouri-Columbia |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Kansas Medical Center |
| ClinicalTrials.gov Identifier: | NCT01700530 History of Changes |
| Other Study ID Numbers: |
09CRP2260136 |
| First Submitted: | September 26, 2012 |
| First Posted: | October 4, 2012 |
| Results First Submitted: | October 14, 2014 |
| Results First Posted: | February 5, 2016 |
| Last Update Posted: | February 5, 2016 |
| Last Verified: | January 2016 |
Keywords provided by University of Kansas Medical Center:
|
mitochondria fitness statins cholesterol metabolic syndrome |
Additional relevant MeSH terms:
|
Syndrome Metabolic Syndrome X Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Simvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors |