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The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones

22. oktober 2020 opdateret af: Seoul National University Hospital
The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital

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

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • type 2 diabetes mellitus
  • HbA1c 6.5~8.5%
  • on life style modification or metformin monotherapy at the time of screening

Exclusion Criteria:

  • on sulfonylurea or insulin therapy at the time of screening
  • allergy to wheat, flour, other cereals or nuts
  • lactose intolerance
  • pregnancy / lactation

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: DF-cereal
  • dietary fiber-enriched cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
  • amount of cereal: 79 g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)
  • one serving (40g) of steamed egg is added for dinner and breakfast
Kosttilskud: dietary fiber-enriched cereal
  • provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
  • amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.)
  • one serving of steamed egg is added for dinner and breakfast
Andet: conventional cereal
  • conventional cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
  • amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)
  • one serving (40g) of steamed egg is added for dinner and breakfast
Andet: conventional cereal
  • provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
  • amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.)
  • one serving (40g) of steamed egg is added for dinner and breakfast

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal
Tidsramme: every 30 minutes from 8 a.m. to noon on the second day
To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels.
every 30 minutes from 8 a.m. to noon on the second day

Sekundære resultatmål

Resultatmål
Tidsramme
AUC of Plasma Total GIP Levels After Intake of the Study Meal
Tidsramme: every 30 minutes from 8 a.m. to noon on the second day
every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucose Levels After Intake of the Study Meal
Tidsramme: every 30 minutes from 8 a.m. to noon on the second day
every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Insulin Levels After Intake of the Study Meal
Tidsramme: every 30 minutes from 8 a.m. to noon on the second day
every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucagon Levels After Intake of the Study Meal
Tidsramme: every 30 minutes from 8 a.m. to noon on the second day
every 30 minutes from 8 a.m. to noon on the second day
AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal
Tidsramme: every 30 minutes from 8 a.m. to noon on the second day
every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Total GIP Levels After Lunch
Tidsramme: every 30 minutes from noon to 4 p.m. on the second day
every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucose Levels After Lunch
Tidsramme: every 30 minutes from noon to 4 p.m. on the second day
every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Insulin Levels After Lunch
Tidsramme: every 30 minutes from noon to 4 p.m. on the second day
every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucagon Levels After Lunch
Tidsramme: every 30 minutes from noon to 4 p.m. on the second day
every 30 minutes from noon to 4 p.m. on the second day
AUC of Serum Free Fatty Acid Levels After Lunch
Tidsramme: every 30 minutes from noon to 4 p.m. on the second day
every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Total GLP-1 Levels After Lunch
Tidsramme: every 30 minutes from noon to 4 p.m. on the second day
every 30 minutes from noon to 4 p.m. on the second day

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University Hospital

Efterforskere

  • Studiestol: Young Min Cho, MD, PHD, Seoul National University College of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. december 2013

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

22. november 2013

Først indsendt, der opfyldte QC-kriterier

22. november 2013

Først opslået (Skøn)

28. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2020

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-1307-133-508
  • 0620132990 (Anden identifikator: SNUH Institutional Review Board)

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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