N/A
N=50
Exercise, Statins, and the Metabolic Syndrome
Metabolic Syndrome · Obese · Sedentary
Bottom Line
View on ClinicalTrials.gov: NCT01700530 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: % Change in VO2max (Fitness) — 0; 10; 1.5 percentage change of VO2max — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Statin (Drug); Exercise only (Other); Statins + Exercise (Other)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Change in VO2max (Fitness) |
0; 10; 1.5 | <0.05 sig |
| SECONDARY Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity) |
0; 13; -4.5 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01700530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.