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Study on the Comparison Between"Standard Noodles" and Traditional Carbohydrates in the Diagnosis of Diabetes Mellitus.

9. oktober 2013 oppdatert av: Guang Ning, Shanghai Jiao Tong University School of Medicine

The object of this study is to compare "100g Standard Noodles " with traditional carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the diagnosis of diabetes mellitus.

In this study, we will compare the different effects of "100g Standard Noodles Tolerance Test"and "75g Oral Glucose Tolerance Test"on plasma glucose, insulin, c- peptide level and the relevant hormones level including glucagon-like peptide-1( GLP-1) and glucagon. Besides, in part of the subjects, the difference between "100g Steamed Bread Tolerance Test", "100g Standard Noodles Tolerance Test" and "75g Oral Glucose Tolerance Test" will be further evaluated.

Studieoversikt

Status

Ukjent

Forhold

Studietype

Intervensjonell

Registrering (Forventet)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Shanghai
      • Shanghai, Shanghai, Kina, 200021
        • Shanghai Jiao Tong University School of Medicine

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

16 år til 70 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Inclusion Criteria:

For healthy subjects:

  1. Between 16-70 years old.
  2. No weight fluctuation greater than 5% within 3 months.
  3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .

For subjects with impaired glucose regulation(IGR):

  1. Between 16-70 years old.
  2. Impaired fasting glucose(IFG):6.1mM(109mg/ml)≤fasting plasma glucose(FPG)<7.0mM(126mg/ml),or impaired glucose tolerance(IGT):7.8mM(140mg/ml)≤2h plasma glucose(2hPG)<11.1mM(200mg/dl),or both.
  3. No weight fluctuation greater than 5% within3 months.
  4. Keep stable antidiabetic therapy for at least 2 months.
  5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .

For subjects with type 2 diabetes mellitus(T2DM):

  1. Between 16-70 years old.
  2. T2DM:diabetic symptoms plus random blood glucose(RBG)≥11.1mM,or FPG ≥7.0mM(126mg/dl),or 2hPG ≥11.1mM(200mg/dl).
  3. No weight fluctuation greater than 5% within 3 months.
  4. Keep stable antidiabetic therapy at least for 2 months.
  5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.

For subjects with type 1 diabetes mellitus(T1DM):

  1. Between 16-70 years old.
  2. T1DM:diabetic symptoms plus RBG≥11.1mM,or FPG ≥7.0mM(126mg/dl),or 2hPG ≥11.1mM(200mg/dl).
  3. Present at least one positive antibody of β cell including ICA,IAA,GADA,IA-2A and IA-2βA.
  4. No weight fluctuation greater than 5% within 3 months.
  5. Keep stable antidiabetic therapy for at least 2 months.
  6. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.

Exclusion Criteria:

For healthy subjects:

  1. Be diagnosed with diabetes or IGR in late 3 months.
  2. With any significant medical condition,laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
  3. Any medical or surgical conditions possibly affecting the experiment result.
  4. Participated in a clinical study involving administration of medication within 90 days.
  5. Donated blood or plasma or had any other significant blood loss within 2 months.
  6. Any clinically significant allergic diseases.
  7. Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
  8. Smokers or users of other tobacco products in the 3 months prior to screening.

For IGR and DM:

  1. History of pancreatic diseases such as pancreatic cancer or pancreatitis.
  2. Suffered from acute complications such as diabetic ketoacidosis and hyperosmolar coma within 3 months.
  3. With any significant medical condition,laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
  4. Malignant tumor.
  5. Being allergic to experiment arms.
  6. Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 100g Standard Noodles
Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.
Eksperimentell: 75g Oral Glucose
Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The plasma glucose level.
Tidsramme: 12 months
The primary outcome measures the plasma glucose level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
12 months
The insulin level.
Tidsramme: 12 months
The primary outcome measures the insulin level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
12 months
The c-peptide level.
Tidsramme: 12 months
The primary outcome measures the c-peptide level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The GLP-1 level.
Tidsramme: 12months
The outcome measures of the GLP-1 level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
12months
The Glucagon level.
Tidsramme: 12 months
The outcome measures of the glucagon level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
12 months
The other relevant incretin hormones levels.
Tidsramme: 12 months
The outcome measures of the relevant incretin hormones level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
12 months
The plasma glucose, insulin, c-peptide and relevant incretin hormones level during "75g Oral Glucose Tolerance Test", "100g Standard Noodles Tolerance Test" and "100g Steamed Bread Tolerance Test".
Tidsramme: 12 months
12 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety
Tidsramme: 12 months
Document the frequency and extent of side-effects.
12 months

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine

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. januar 2013

Primær fullføring (Forventet)

1. oktober 2013

Studiet fullført (Forventet)

1. desember 2013

Datoer for studieregistrering

Først innsendt

29. september 2013

Først innsendt som oppfylte QC-kriteriene

9. oktober 2013

Først lagt ut (Anslag)

10. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. oktober 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. oktober 2013

Sist bekreftet

1. oktober 2013

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CCEMD018

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. .

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