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Yoga for the Treatment of Metabolic Syndrome

30. januar 2008 opdateret af: University of California, San Francisco

Restorative Yoga for Therapy of the Metabolic Syndrome: A Pilot Trial

We tested the following hypotheses:

  1. That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and other features of the metabolic syndrome such as hypertension and dyslipidemia (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting blood tests, and a physical examination before and after randomization of subjects to a 10-week yoga therapy intervention or wait-list control group.
  2. That a yoga therapy is feasible in overweight and underactive individuals with the metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga therapy is associated with improved quality of life, we will assess the adherence to twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life before and after the intervention in both treatment groups.
  3. To elucidate a potential mechanism for the effect of yoga on changes in insulin resistance by evaluating markers of inflammation from adipose tissue (adipocytokines). We hypothesize that these biochemical parameters will show modest improvement with yoga therapy and that changes in these parameters will be associated with improvements in insulin sensitivity.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Interventions: There will be a 12-week intervention period.

  1. Yoga Therapy Group: Those randomized to yoga therapy will receive twice-weekly group yoga sessions at the Osher Center for the entire intervention period. The yoga postures and breathing techniques will be taught by a qualified and certified yoga instructor using a standardized protocol that was determined by a Yoga Expert Panel. Each group yoga session will take approximately 90 minutes. Participants will also be required to practice yoga at home at least 3 times per week, and be given yoga materials (mat, blocks, straps), an instruction manual, and a video for their use at home. They will be asked to keep a calendar log of the dates/times that they practiced yoga at home. This group will also receive a 20-30 minute session with a counselor to discuss Standard Health Education at the beginning of the 12-week intervention. This session will be similar to the control group intervention.
  2. Standard Health Education Group: Participants assigned to the standard health education group will receive an individual 20-30 minute session with a trained research associate within a week of their baseline visit. In this session, participants will be informed of the importance of a healthy lifestyle, given written information of the Food Guide Pyramid12 and told to follow the equivalent of the National Cholesterol Education Program Step I diet13. They will be counseled to reduce weight and increase physical activity. This is similar to the intervention given to the "Standard Lifestyle Group" in the Diabetes Prevention Program4.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94115
        • University of California, San Francisco

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

30 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. to be between the ages of 30 and 65 years,

  2. fulfill at least three criteria for the metabolic syndrome per the NCEP guidelines:

    • waist circumference (>88 cm for women; >102 cm for men),
    • HDL-cholesterol (<50 mg/dl for women; <40 mg/dl for men),
    • triglycerides >=150 mg/dL
    • fasting glucose >=100 mg/dL, and/or
    • high blood pressure (>=130/>=85 or use of antihypertensive medication), and
  3. report an underactive or sedentary lifestyle defined as accumulating less than 30 minutes of moderate intensity endurance exercise 5 days per week.

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Coronary heart disease (defined as a myocardial infarction or cardiac intervention with percutaneous transluminal catheterization or coronary artery bypass graft surgery) event or hospitalization in the past 6 months
  3. Chronic illnesses: cancer, kidney disease, cirrhosis, rheumatogic diseases, or chronic infections
  4. Current use of these medications: oral diabetes medications, insulin, steroid hormones, oral contraceptives, hormone replacement therapy, niacin, fibrates.
  5. Regular participation (>1/week) yoga for past 3 months or concurrent use of yoga
  6. Current major psychiatric illness, cognitive impairment, or substance abuse
  7. Plans to move out of the study region within 6 months
  8. Life-expectancy of < 6 months
  9. Concurrent enrollment in any other studies, experimental therapies, or blinded treatments

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A
Restorative yoga therapy group: one orientation workshop for 3 hours, then twice-weekly group yoga therapy classes for first 5 weeks followed by once-weekly group yoga classes for another 5 weeks. The group will also be asked to practice their yoga postures at home for 30 minutes three times per week.
Adfærdsmæssigt: Restorative yoga therapy
3-hour workshop at study initiation. Then twice-weekly group yoga classes for 5 weeks, then once-weekly group yoga classes for 5 weeks. Home yoga practice for 90 minutes/week throughout the 10 week trial.
Ingen indgriben: B
The control group is a wait-list control group with no active intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Fasting plasma glucose level
Tidsramme: 10 weeks
10 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Blodtryk
Tidsramme: 10 uger
10 uger
Feasability of yoga postures
Tidsramme: 10 weeks
10 weeks
Adherence to protocol
Tidsramme: 10 weeks
10 weeks
Insulin sensitivity
Tidsramme: 10 weeks
10 weeks
Weight
Tidsramme: 10 weeks
10 weeks
Waist circumference
Tidsramme: 10 weeks
10 weeks
Heart rate variability
Tidsramme: 10 weeks
10 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, San Francisco

Samarbejdspartnere

Cliff Lede Foundation

Efterforskere

  • Ledende efterforsker: Alka M. Kanaya, MD, University of California, San Francisco

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. oktober 2006

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først indsendt

16. januar 2008

Først indsendt, der opfyldte QC-kriterier

30. januar 2008

Først opslået (Skøn)

31. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. januar 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2008

Sidst verificeret

1. januar 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H9377-29543-02
  • CHR#H9377-29543-02

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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