- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616498
Lean Muscle Function (LEAN)
Obesity and Muscle Function Pilot Study
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Winston Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age=65-75 years
- BMI=18-24 kg/m2
- No resistance training for past 6 months
- Normal cognitive function (MMSE >24)
- No contraindications for participation in weight loss or weight lifting exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year
- Able to provide own transportation to study visits
- Not involved in any other research study involving strength training or undergoing physical therapy
- Not dependent on a cane or walker
- Willing to provide informed consent
Exclusion Criteria:
- Weight loss or gain (±5%) in past 6 months
- Body mass >136 kg (DXA limit)
- Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
- Insulin dependent or uncontrolled diabetes (FBG >140 mg/dL)
- Uncontrolled hypertension (BP>180/100 mmHg)
- Abnormal kidney function or liver blood tests
- Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>2 mm) on ECG
- Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus. These will be reviewed on a case by case basis.
- Past or current respiratory disease (requiring steroid treatment or supplemental oxygen)
- Past or current clinical diagnoses of neurological or hematological disease
- Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox)
- Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
- Clinically evident edema or anemia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lean
Comparison data from this lean cohort will be compared to the obese older adults are already being collected in an R01-funded study (Improving Muscle for Functional Independence Trial; IRB00009098; NCT01049698)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Fiber
Time Frame: Baseline
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Primary Aim: To measure single muscle fiber contractile properties, including specific force, unloaded shortening velocity, and maximum power. We will also measure whole muscle strength and size and fiber fat infiltration. These results will establish a reference database against which data recorded in older obese individuals can be compared. Primary hypothesis: Single muscle fibers will exhibit more force and power in healthy non-obese than obese older adults due to greater intra-myocellular fat infiltration. |
Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength
Time Frame: Baseline
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Non-obese older adults will exhibit greater whole muscle strength (absolute and relative to muscle mass and volume) and power than obese, older adults.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00019632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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