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Evaluation of Gut Absorption Rate of Glucose After a Large Evening Meal in Type 1 Diabetes

20. mai 2016 oppdatert av: David Dunger, University of Cambridge

Validation of the Gut Absorption Rate of Glucose During a Large, Slowly and Rapidly-absorbed Evening Meal in Subjects With Type 1 Diabetes

Eight adolescent and young adult subjects with type 1 diabetes, age 16-24 years, will be recruited for this study on the basis of informed consent. Participants will be invited to attend the Wellcome Trust Clinical Research Facility at Addenbrooke's Hospital, Cambridge, on two occasions. On each occasion participants will arrive at the unit at 9am having controlled their diabetes with short acting insulin for 24 hours and they will remain in the unit until 8am the next morning. During the day, between 9am and 6pm participants will remain fasting and their blood glucose levels will be controlled by intravenous insulin, the dose being determined by 15-30 minute blood glucose estimations. At 1800hr on visit 1 the subjects will be asked to ingest an evening meal enriched by a cold isotope glucose tracer (non radioactive). The variable insulin infusion will be adjusted to allow for the meal in order to achieve good glycaemic control after the meal until 0200hr. From then until 0800hr in the morning the study team will again adjust the infusion rates to maintain normal glycemia until the participants are ready to go home on their normal insulin regimen. On the second visit the protocol will be identical until 1800hr when instead of giving the meal variable amounts of glucose will be infused to ensure the glucose levels are identical to those observed on visit 1. After 0200hr the study will be effectively finished but the study team will continue to vary the insulin infusion to keep blood glucose levels normal until the subjects can go home on their normal insulin regime at 8am.

In order to achieve sufficient information to make all the calculations needed other cold isotope glucose tracers will be infused during the study period. These safe non radioactive isotope tracers will enable us to assess glucose being produced by the body, its distribution and utilization. Throughout both study periods the subjects will be monitored very closely by a Clinical Research Fellow, assisted by a Research Nurse, in order to avoid any risk of low blood glucose levels.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

16

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 24 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Young adults with type 1 diabetes

Beskrivelse

Inclusion Criteria:

  • The subject is between 16 and 24 years of age (inclusive)
  • The subject has type 1 diabetes, as defined by WHO for at least 6 months or is confirmed C-peptide negative
  • The subject will have been on insulin pump or MDI therapy for at least 6 months
  • Body Mass Index (BMI) < 30 kg/m2
  • HbA1c ≤ 12 % based on analysis from central laboratory

Exclusion Criteria:

  • Non-type 1 diabetes mellitus including those secondary to chronic disease
  • Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
  • Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
  • Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator)
  • Known or suspected allergy against insulin
  • Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator.
  • Total daily insulin dose = 1.4 IU/kg.
  • Pregnancy or intention of becoming pregnant, breast-feeding or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods
  • Gastroparesis
  • Symptomatic hypoglycaemia within 48h prior to study nights
  • Moderate or intense exercise within 24h prior to study nights

Studieplan

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

Hvordan er studiet utformet?

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To measure the rate of glucose absorption after a standard evening meal
Tidsramme: Through study completion, up to 2 years, from date of randomization until the date of completion of data analysis
Validation of the rate of glucose absorption after a large, slowly and rapidly-absorbed evening meal in subjects with type 1 diabetes.
Through study completion, up to 2 years, from date of randomization until the date of completion of data analysis

Samarbeidspartnere og etterforskere

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

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 2008

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først innsendt

17. desember 2015

Først innsendt som oppfylte QC-kriteriene

20. mai 2016

Først lagt ut (Anslag)

25. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

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. .

Kliniske studier på Type 1 diabetes

3
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