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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT01727349
First received: November 8, 2012
Last updated: November 19, 2013
Last verified: November 2011
  Purpose

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


Condition Intervention
Type 2 Diabetes
Other: HbA1c measurement
Other: Oral Glucoce Tolerance Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • Measure of risk of developing type 2 diabetes in at-risk families [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Oral Glucose Tolerance Test (only for health volunteers) HbA1c assay (for type 2 diabetic subject)


Estimated Enrollment: 3000
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Type 2 diabetic subject
Subject with type 2 diabetes
Other: HbA1c measurement
healthy subject
Healthy subjet from family where there is the existence of the disease (type 2 diabetes) in two successive generations
Other: Oral Glucoce Tolerance Test
Oral Glucoce Tolerance Test

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 35 years

Exclusion Criteria:

  • subject refusing to participate
  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727349

Contacts
Contact: Guillaume CHARPENTIER, MD +33164969599

Locations
Belgium
CHU Sart Tilman Liège Recruiting
Liege, Belgium, 4000
Contact: Andre Scheen, MD PHD         
Sub-Investigator: Régis RADERMECKER, MD         
Principal Investigator: Andre Scheen, MD PHD         
France
CHU Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Alfred PENFORNIS, MD PHD         
Principal Investigator: Alfred PENFORNIS, MD PHD         
Sub-Investigator: Annie CLERGEOT, MD         
CHU de Bondy Recruiting
Bondy, France
Contact: Emmanuel Cosson, MD PHD         
Principal Investigator: Emmanuel Cosson, MD PHD         
CHU de Caen Recruiting
Caen, France, 14000
Contact: Yves REZNIK, MD         
Principal Investigator: Yves REZNIK, MD PHD         
Sub-Investigator: Michael JOUBERT, MD         
Sub-Investigator: Anne ROD, MD         
Sub-Investigator: Julia MORERA, MD         
CH Sud Francilien Recruiting
Evry, France, 91000
Contact: Guillaume Charpentier, MD         
Principal Investigator: Guillaume CHARPENTIER, MD         
University Hospital Grenoble Recruiting
Grenoble, France, 38043
Contact: Pierre Yves Benhamou, MD PhD         
Principal Investigator: Pierre Yves Benhamou, MD PhD         
CHRU Lille Recruiting
Lille, France, 59037
Contact: Pierre Fontaine, MD PHD         
Principal Investigator: Anne WAMBERGUE, MD         
Principal Investigator: Pierre FONTAINE, MD PHD         
CHU Marseille Hôpitaux Sud Recruiting
Marseille, France, 13274
Contact: Catherine Zevaco Mattei, MD         
Sub-Investigator: Pauline SCHAEPELYNCK-BELICAR, MD         
Principal Investigator: Catherine ZEVACO MATTEI, MD         
CHU de Nancy Recruiting
Nancy, France, 54500
Contact: Bruno GUERCI, MD PHD         
Principal Investigator: Bruno GUERCI, MD PHD         
Centre Hospitalier Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Nathalie Jeandidier, MD PHD         
Sub-Investigator: Nathalie JEANDIDIER, MD PHD         
CHU Toulouse Recruiting
Toulouse, France, 31403
Contact: Hélène Hanaire, MD PHD         
Principal Investigator: Hélène HANAIRE, MD         
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT01727349     History of Changes
Other Study ID Numbers: 2011-A00686-35
Study First Received: November 8, 2012
Last Updated: November 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014