Clinical trial NCT01616498: Lean Muscle Function
Official title: Obesity and Muscle Function Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single Muscle Fibers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 sedentary, normal-weight (BMI= 18-24 kg/m2) older (65-75 yrs) men and women (n=10 each)

Brief summary: This pilot study is designed to determine the relationship between intra-myocellular lipids and muscle contractility in fibers from obese and non-obese older adults. Obese participants are being recruited for an on-going weight loss intervention study and this application seeks approval to recruit and enroll a lean comparison group of non-obese older adults. The primary goal of this study is to characterize the contractile properties of single muscle fibers and whole muscle in healthy, non-obese individuals under the same recording conditions the investigators used for the obese population to begin to determine whether fat infiltration accounts for diminished force.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle Fiber
timeFrame: Baseline
Secondary outcomes:
measure: Muscle Strength
timeFrame: Baseline
Other outcomes:
Locations:
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Barbara Nicklas, PhD
role: PRINCIPAL_INVESTIGATOR
References: