Lean Muscle Function (LEAN)
10. mars 2017 oppdatert av: Barbara Nicklas, PhD, Wake Forest University
Obesity and Muscle Function Pilot Study
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
24
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Winston Salem, North Carolina, Forente stater, 27157
- Wake Forest University Health Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år til 75 år (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
20 sedentary, normal-weight (BMI= 18-24 kg/m2) older (65-75 yrs) men and women (n=10 each)
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Muscle Fiber
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Muscle Strength
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2012
Primær fullføring (Faktiske)
1. september 2013
Studiet fullført (Faktiske)
1. november 2013
Datoer for studieregistrering
Først innsendt
7. juni 2012
Først innsendt som oppfylte QC-kriteriene
8. juni 2012
Først lagt ut (Anslag)
11. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB00019632
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement.
This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source.
All data files will be de-identified.
In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded.
We will create a link on our website that describes our study and the data available for data sharing with descriptions.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .