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Validation of a Predictive Risk Equation for Type 2 Diabetes in Families With Risk (DESCENDANCE)

7. maj 2021 opdateret af: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Validation of a Predictive Risk Equation for Type 2 Diabetes in Children With Diabetes to Achieve a Predictive Diagnostic Biochip for the Early Detection of Individuals at Risk in Families.

Considering its epidemic-like development worldwide, associated with modifications in lifestyle, as well as its enormous social and economic weight, the prevention of type II diabetes is certain to be a central concern of health systems within the developed countries in the decades to come. However, while simple obesity concerns the entire population, type 2 diabetes affects only one sub-population at high genetic risk. To be effective and realistic in economic terms, efforts at prevention must be thus targeted towards these subjects at high risk. The key issue involves identifying such subjects early enough so that a strategy of effective prevention can be organized in good time.

Until now, efforts have been concentrated on individuals at risk for diabetes readily identifiable within the general population, typically subjects in the second half of adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive lifestyle and dietary measures are proposed but are constrictive and difficult to maintain over time, and the results, although they may be significant, remain disappointing, with mere postponement of an outcome which at this stage appears inevitable. The reason is ascribable to excessively tardy intervention, when the pathogenic process has already been ongoing for some ten years and the endocrine function of the pancreas is probably already irreparably impaired.

The alternative thus is earlier intervention, in childhood, adolescence or early adulthood. The problem is to identify individuals at high risk of becoming diabetic at a time when they are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The familial character of type 2 diabetes is now well established, and future diabetic subjects are themselves above all the children of diabetic subjects. However, the prevalence of the disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive tools are needed to combat diabetes in these high-risk families.

We propose to create a risk equation using an algorithm to reliably predict children most likely to develop diabetes later in life.

The algorithm will include 3 classes of data:

  • The genotype stemming from the genetic characterization of individuals and those their parents;
  • Environmental data concerning childhood, especially eating habits and physical activity;
  • Data of the mother who was eventually diabetic during pregnancy.

From a methodological standpoint, it would be rather difficult to take blood samples from children and wait some 50 years to determine whether or not they develop diabetes. To circumvent this difficulty, we will recruit subjects in families with a history of type II diabetes:

  • Parents alive, including at least one type 2 diabetic subject
  • Adult children (aged over 35 years), some of whom are already presenting type II diabetes, and healthy brothers and sisters, who form the control population. Test will be done to determine whether healthy subjects are really safe from the risk of diabetes (HbA1c measurement and glucose load test).

The Descendence study will include 500 families at risk involving about 3000 subjects (1000 subjects with diabetes and 2000 healthy subjects). It is expected to answer the following question: for a child born in such families at risk, what is the probability of developing diabetes later in life, so that early preventive action may be taken

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1035

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Liege, Belgien, 4000
        • CHU Sart Tilman Liege
  • Frankrig
      • Besancon, Frankrig, 25030
        • CHU Jean Minjoz
      • Bobigny, Frankrig, 93000
        • CHU Avicenne
      • Bondy, Frankrig
        • CHU de Bondy
      • Brest, Frankrig
        • CHU de Brest
      • Caen, Frankrig, 14000
        • CHU de Caen
      • Evry, Frankrig, 91000
        • CH Sud Francilien
      • Grenoble, Frankrig, 38043
        • University Hospital Grenoble
      • Le Kremlin-Bicêtre, Frankrig, 94270
        • CHU de Bicetre
      • Lille, Frankrig, 59037
        • CHRU LILLE
      • Marseille, Frankrig, 13274
        • CHU Marseille Hôpitaux Sud
      • Nancy, Frankrig, 54500
        • CHU de NANCY
      • Nantes, Frankrig, 44000
        • CHU de Nantes
      • Paris, Frankrig, 75877
        • CHU Bichat
      • Reims, Frankrig
        • CHU de Reims
      • Strasbourg, Frankrig, 67000
        • Centre Hospitalier Strasbourg
      • Toulouse, Frankrig, 31403
        • CHU Toulouse

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

25 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Families at risk for diabetes defined by the existence of the disease in two successive generations and consists with healthy subject in the two generations.
  • Subjects must be aged over 25 years

Exclusion Criteria:

  • subject refusing to participate
  • pregnant women

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Type 2 diabetic subject
Subject with type 2 diabetes
Andet: HbA1c measurement
Andet: healthy subject
Healthy subjet from family where there is the existence of the disease (type 2 diabetes) in two successive generations
Andet: Oral Glucoce Tolerance Test
Oral Glucoce Tolerance Test

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measure of risk of developing type 2 diabetes in at-risk families
Tidsramme: participants will be followed from the moment where they sign consent form and until they have sent back questionnary and done the blood test, an expected average of 4 weeks
Oral Glucose Tolerance Test (only for health volunteers) HbA1c assay (for type 2 diabetic subject)
participants will be followed from the moment where they sign consent form and until they have sent back questionnary and done the blood test, an expected average of 4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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 (Faktiske)

14. december 2011

Primær færdiggørelse (Faktiske)

24. november 2020

Studieafslutning (Faktiske)

24. november 2020

Datoer for studieregistrering

Først indsendt

8. november 2012

Først indsendt, der opfyldte QC-kriterier

12. november 2012

Først opslået (Skøn)

16. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2021

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-A00686-35

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

Kliniske forsøg med HbA1c measurement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner