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Age, Lifestyle, Muscle Mechanisms in Insulin Resistance

2. september 2009 opdateret af: National Institute on Aging (NIA)
The purpose of this study is to investigate the mechanisms by which physical inactivity and obesity alter skeletal muscle insulin signaling to cause insulin resistance and increase the development of impaired glucose tolerance (IGT).

Studieoversigt

Detaljeret beskrivelse

Aging is associated with a progressive development of impaired glucose tolerance (IGT), due to an increased peripheral tissue resistance to the action of insulin. Insulin resistance, a common state in both obese and sedentary individuals, eventually leads to the development of glucose intolerance, and type 2 diabetes with aging. Even in the absence of diabetes, insulin resistance is a key feature in various metabolic abnormalities that increase the risk for developing cardiovascular disease (CVD). Previous studies demonstrate improvements in glucose tolerance and glucose utilization following moderate energy restriction coupled with moderate intensity AEX. WL, through behavioral modification of diet and aerobic exercise (AEX), is perhaps the most effective way to treat as well as prevent insulin resistance and its associated metabolic complications of IGT and type 2 diabetes. Although these studies demonstrate the beneficial effect of weight loss (WL) and AEX on glucose tolerance and insulin action, not much is known about the cellular and molecular mechanisms by which these nonpharmacologic treatments improve glucose utilization in high-risk obese older individuals.

This study seeks to determine the cellular mechanisms by which aerobic exercise and weight loss alter skeletal muscle insulin signaling to improve insulin action in older glucose intolerant individuals. A second purpose is to determine whether certain genes (hereditary information) affect the way the body utilizes glucose in response to exercise and weight loss. In addition, adipose tissue is increasingly recognized as more than an inert depot serving not only to accept and store excess energy in the form of triglycerides, but also to secrete hormones and adipokines that have substantial effects on lipid and glucose metabolism. Furthermore, there are depot differences in metabolic function, as well as adipokine content. However, the physiology both underlying and consequential to these observations remains unknown. Thus, a third aim is to examine the effects of obesity on regional adipokine secretion and expression, and the relationship of adipokines to insulin resistance and the metabolic syndrome.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Baltimore VA Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Men older than 50 yrs of age
  • Non-smoking (more than 5 years)
  • BMI greater than 25 kg/m2 and less than 50 kg/m2

Exclusion Criteria:

  • CAD, CHF, Myocardial infarction within 6 months or other symptomatic heart disease
  • History of stroke, peripheral arterial disease
  • Currently being treated for active cancer
  • On oral agents or insulin therapy for diabetes
  • Poorly controlled Dyslipidemia (abnormal concentration of lipids or lipoproteins in the blood)
  • Poorly controlled hypertension (BP > 180/95)
  • Other systematic disorders that are not medically treated and stable
  • Physical impairment limiting normal activity and other contraindications to exercise
  • Aerobically conditioned
  • Abnormal response to exercise (chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP > 240/120)
  • Taking warfarin/coumadin
  • Taking oral steroids
  • Abnormal renal function or liver function
  • Chronic pulmonary disease severe enough to require oxygen
  • Anemia
  • MMSE < 24, dementia

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: WL+AEX
Weight loss plus aerobic exercise
1 hour sessions, once per week, with a registered dietitian on the American Heart Association Step I diet with caloric intake for each volunteer adjusted by the dietitian to elicit a WL of ~0.2-0.4 kg/wk
Moderate aerobic exercise (75-80% HRR for 45 min) at the Baltimore GRECC exercise facility using treadmills 3 times per week for 6 months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Insulin stimulated glucose disposal
Tidsramme: Baseline and 6 months
Baseline and 6 months
Content and activity of insulin signaling proteins from muscle biopsies
Tidsramme: Baseline and 6 months
Baseline and 6 months
Glucose tolerance
Tidsramme: Baseline and 6 months
Baseline and 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Aerobic capacity
Tidsramme: Baseline and 6 months
Baseline and 6 months
Body weight/Composition
Tidsramme: Baseline and 6 months
Baseline and 6 months
Cytokines
Tidsramme: Baseline and 6 months
Baseline and 6 months
Other biomarkers (such as glucose, insulin etc)
Tidsramme: Baseline and 6 months
Baseline and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Lyndon Joseph, PhD, National Institute on Aging (NIA)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2004

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

2. september 2009

Først indsendt, der opfyldte QC-kriterier

2. september 2009

Først opslået (Skøn)

3. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. september 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2009

Sidst verificeret

1. september 2009

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AG0120
  • K01AG021457 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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