Exercise, Statins, and the Metabolic Syndrome

NCT01700530 | Completed Results

• 1 other identifier: 09CRP2260136
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Obese; Sedentary

Keywords

mitochondria; fitness; statins; cholesterol; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• % Change in VO2max (Fitness)

  % change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max

  Change from Baseline to 12 weeks

Secondary Outcomes (1)

• Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)

  12 weeks

Study Arms (3)

Statin

EXPERIMENTAL

Statins (40mg/day)for an average of 12 weeks

Drug: Statin

Exercise only

EXPERIMENTAL

12 weeks of exercise training (5 days a week for 45-50 min a session)

Other: Exercise only

Statins + Exercise

ACTIVE COMPARATOR

Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks

Other: Statins + Exercise

Interventions

Statin DRUG

Statins (40mg/day)for 12 weeks

Also known as: simvastatin

Statin

Exercise only OTHER

12 weeks of exercise training (5 days a week for 45-50 min a session)

Also known as: Physical activity

Exercise only

Statins + Exercise OTHER

Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks

Also known as: Statins + Physical Activity

Statins + Exercise

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• University of Missouri-Columbia: collaborator
• American Heart Association: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

• 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.

  PMID: 23583255 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Sedentary Behavior

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: John P. Thyfault, PhD
• Organization: University of Missouri

thyfaultj@missouri.edu

573-874-9728

Study Officials

• John P Thyfault, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 4, 2012
• Study Start: May 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 5, 2016
• Results First Posted: February 5, 2016

Record last verified: 2016-01

Locations

US (1)