Lifestyle Control of Postprandial Hyperglycemia
1. august 2017 oppdatert av: Jonathan Little, University of British Columbia
Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels.
Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and inflammation.
We will examine how following a short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts markers of blood vessel function and inflammation.
We will also examine how a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control and blood vessel function.
Findings will help determine the best lifestyle approach for improving cardiovascular health in type 2 diabetes.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia, Okanagan.
-
-
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
40 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosed with type 2 diabetes (at least 6 months ago)
- Aged 40-75
- Engaging in 2 or less moderate-to-vigorous exercise bouts per week in the last 3 months
- Ability to understand and communicate in English to interact with the personal trainer
Exclusion Criteria:
- Diagnosed coronary artery disease
- Any contraindications to exercise (e.g., musculoskeletal injury)
- Prior history of cardio- or cerebrovascular disease or myocardial infarction
- Hypertension that is not controlled by medication (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >99 mmHg)
- Change in diabetes medications in the previous 6 months
- Diagnosed with peripheral neuropathy
- Taking exogenous insulin
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: High-carbohydrate diet
|
Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association.
The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat.
Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
|
|
Eksperimentell: Low-carbohydrate diet
|
Participants will engage in 4 days of low-carbohydrate high-fat diet.
The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat.
Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
|
|
Eksperimentell: Low-carbohydrate diet with post-meal walking
|
Participants will engage in 4 days of low-carbohydrate high-fat diet.
The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat.
Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner.
Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
Tidsramme: 4-day average glucose levels assessed in each arm.
|
4-day average glucose levels assessed in each arm.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
Tidsramme: Fasting measurements taken on day 1 and day 5.
|
Fasting measurements taken on day 1 and day 5.
|
|
Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.
Tidsramme: Fasting measurements taken on day 1 and day 5.
|
Fasting measurements taken on day 1 and day 5.
|
|
Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.
Tidsramme: Fasting measurements taken on day 1 and day 5.
|
Fasting measurements taken on day 1 and day 5.
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in flow-mediated dilation after single breakfast meal on day 1 of the intervention
Tidsramme: Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
|
Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
|
|
Change from baseline in plasma glucose after single breakfast meal on day 1 of the intervention
Tidsramme: Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
|
Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
|
|
Change from baseline in body weight after a single meal and 4 days of intervention.
Tidsramme: Fasting measures on day 1 and day 5.
|
Fasting measures on day 1 and day 5.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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. november 2015
Primær fullføring (Faktiske)
1. juni 2017
Studiet fullført (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først innsendt
11. februar 2016
Først innsendt som oppfylte QC-kriteriene
11. februar 2016
Først lagt ut (Anslag)
17. februar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H1501952
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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. .