Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease

27. januar 2009 oppdatert av: Queen's University

Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease

Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load.

To date, there have not been any prospective randomized studies which examine the utility of a low glycemic load diet.

The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.

Studieoversikt

Detaljert beskrivelse

The primary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.

The secondary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease. The purpose of this portion of the study is to try to elucidate the relative contributions of the glycemic index and carbohydrate content to the overall effectiveness of a low glycemic load diet. Furthermore, through detailed analysis of actual dietary consumption, and correlation with subsequent weight loss, we hope to gain greater insight into the role of compliance on the success of the various dietary strategies. Restriction of caloric intake is necessary for weight loss regardless of the dietary strategy employed, however, long-term success depends ultimately on the ability of the patients to comply with the said diet. The success of a low glycemic load diet may lie in its superior effectiveness (greater compliance, less calorie consumption) rather than a greater efficacy per se.

A secondary analysis of the effects of all three diets (low glycemic load, low glycemic index and low carbohydrate) on modifying other metabolic factors will also be performed. In particular, the study will examine the effect of the three diets on lipid and fat metabolism, insulin resistance and inflammation.

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Vascular Disease Prevention and Research Centre

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women, aged 18 to 80 years
  • BMI 25-40 kg/m2
  • Documented Cardiovascular Disease as evidenced by one or more of the following:

    • Coronary atherosclerosis during coronary angiography
    • Documented myocardial infarction
    • Carotid atherosclerosis during carotid ultrasonography
    • Carotid atherosclerosis during CT angiography
    • Carotid atherosclerosis during MR angiography
    • Ischemic brain infarct documented on brain imaging studies

Exclusion Criteria:

  • Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada)
  • Previous (<5 years ago) individual or group dietary counseling with a registered dietician
  • Pregnant or lactating women
  • Presence of clinically important hepatic or renal disease
  • Inability to communicate effectively using the English language
  • Enrollment in another study concurrently
  • Inability to give informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 1
Low glycemic load diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Annen: 2
Canada Food Guide Diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Annen: 3
Low glycemic index diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Annen: 4
Low carbohydrate diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Tidsramme
To compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease.
Tidsramme: 1 year
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Stephen A LaHaye, MD, Vascular Disease Prevention and Research Centre

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. september 2004

Primær fullføring (Faktiske)

1. januar 2009

Studiet fullført (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først innsendt

9. september 2005

Først innsendt som oppfylte QC-kriteriene

28. september 2005

Først lagt ut (Anslag)

29. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. januar 2009

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. januar 2009

Sist bekreftet

1. januar 2009

Mer informasjon

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. .

Kliniske studier på Low glycemic load diet

3
Abonnere