Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Lifestyle Therapy for Youth With Type 2 Diabetes (BDT)

28. juli 2014 opdateret af: Jon McGavock, University of Manitoba

Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes

Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).

Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period.

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0P4
        • Manitoba Institute of Child Health

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

10 år til 20 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • youth with a BMI considered overweight according to the International Obesity Task Force
  • diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment

Exclusion Criteria:

  • youth with type 1 diabetes
  • use of insulin or other anti-diabetic drugs
  • youth with medication-induced diabetes
  • youth who have recently been admitted to hospital with ketoacidosis
  • youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
  • youth with an orthapaedic injury preventing them from exercising
  • youth who have a history of alcohol or drug abuse

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lifestyle counselling
Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting
Adfærdsmæssigt: Lifestyle Counselling
Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
Ingen indgriben: Control
Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
Tidsramme: 16 weeks
16 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiometabolic risk Z score
Tidsramme: 16 weeks
This is a composite score based on BMI z-score, waist circumference, c-reactive protein (CRP), fibrinogen, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides (TG) and apolipoprotein B (apoB), and a marker of fatty liver disease, alanine transaminase (ALT)
16 weeks
Presence of microalbuminuria
Tidsramme: 16 weeks
defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection
16 weeks
Hypertension
Tidsramme: 16 weeks
defined as a systolic blood pressure load >25% or a mean 24 hour systolic blood pressure >95th %ile for sex and height on 24 hour ambulatory blood pressure monitoring
16 weeks
Anthropometrics
Tidsramme: 16 weeks
Waist circumference in centimeters, body mass index (BMI) z-score and percent body fat will be assessed to determine if changes in body composition are associated with improvements in cardiometabolic risk
16 weeks
Cardiovascular structure and function
Tidsramme: 16 weeks
Vascular health will be assessed with non-invasive assessments of arterial stiffness, endothelium-dependant relaxation and carotid intima media thickness which will be treated as continuous variables. Left ventricular structure and function will be assessed using standard M-mode and doppler ultrasound techniques
16 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of Manitoba

Samarbejdspartnere

Manitoba Institute of Child Health

Efterforskere

  • Ledende efterforsker: Jonathon McGavock, PhD, University of Manitoba

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 2012

Primær færdiggørelse (Faktiske)

1. maj 2014

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

9. maj 2012

Først indsendt, der opfyldte QC-kriterier

10. maj 2012

Først opslået (Skøn)

11. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2012:023

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 Type 2 diabetes mellitus

Kliniske forsøg med Lifestyle Counselling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner