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

27. januar 2009 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

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

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

Efterforskere

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

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. september 2004

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

9. september 2005

Først indsendt, der opfyldte QC-kriterier

28. september 2005

Først opslået (Skøn)

29. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. januar 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2009

Sidst verificeret

1. januar 2009

Mere information

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 .

Kliniske forsøg med Low glycemic load diet

3
Abonner