Lean Muscle Function

NCT ID: NCT01616498

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-11-30

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.

Conditions

Single Muscle Fibers

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Barbara Nicklas, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Nicklas, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00019632

Identifier Type: -

Identifier Source: org_study_id