Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis (GDM)

28 novembre 2011 mis à jour par: Naomi Meyerstein, Soroka University Medical Center

Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style

Diabetes Mellitus (DM) is a chronic metabolic disorder with increasing incidence and long term complications. Its incidence differs in various ethnic populations.Gestational DM (GDM) is diagnosed when impaired glucose tolerance (IGT) is first detected during pregnancy. GDM incidence in Jewish and Bedouin women has been rising in recent years. It has been reported in many studies that women who had been diagnosed with GDM are more prone to GDM in their next pregnancies and to DM Type 2.

Appropriate changes in everyday diet and physical exercise may reduce the chances for future GDM and type 2 DM.

The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin populations and to construct a plan for follow up and reduce future problems by changing their life style.

Aperçu de l'étude

Description détaillée

Diabetes Mellitus is a very common chronic metabolic disorder,currently an epidemic with correlation to obesity. DM frequency differs as a function of population characteristics factors. In Israel it is more prevalent in Jews than in Bedouins. However, lately, there has been a rise in DM frequency in the Bedouin population. This rise is probably due to the change in life style from the traditional way of life towards a western one, characterized by change in food habits and decrease in physical activity. This combination may lead to increased body mass index (BMI)and to DM.

Many studies report higher incidence of DM type 2 following Gestational Diabetes Mellitus (GDM). GDM is defined as glucose intolerance which is detected during pregnancy in healthy women. Its frequency varies between 1 to 14% in pregnant women in different populations. Although usually glucose intolerance disappears after delivery,many of these women may develop future GMD or DM type 2. This can be delayed or even prevented by appropriate diet and increased physical activity.

The aim of our study was:

  1. To determine GDM frequency in Jewish and Bedouin populations in the Negev area in southern Israel.
  2. To approach Jewish and Bedouin GDM women before discharge from the hospital and invite them to join the study and divide them into intervention group and control respectively.
  3. To study whether intervention in life style leads to similar results in both populations.
  4. To propose a model for predicting persistent lifestyle change intervention.

The study included 180 women diagnosed with GDM ,133 Jewish and 47 Bedouin women.The women were divided in two groups, an intervention group (77 Jewish and 26 Bedouin) and control ones (56 Jewish and 21 Bedouin women). At their first visit, 3 months after delivery all women filled forms about demographic data, nutrition and physical habits. All of them, including the control group were given full information about GDM and increased risk for DM.

All the women signed their informed consent forms for participation in the study. The intervention group had several group meetings every several months. Metabolic parameters were determined, including plasma insulin ,glucose and lipids levels.Height, weight, BMI, blood pressure and abdominal circumference were measured too. The same parameters were determined one and two years post partum. The intervention group had several group meetings every several months with a dietician and a physical exercise instructor.

Type d'étude

Interventionnel

Inscription (Réel)

180

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 43 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Diagnosis of gestational diabetes.

Exclusion Criteria:

  • Diabetes Mellitus

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Post GDM follow-up group.
Every several months the women had instructions and checkups.
Autres noms:
  • Jew and Bedouin women with recent GDM in the Negev area.
Expérimental: lifestyle intervention group.
The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
Every several months the women had instructions and checkups.
Autres noms:
  • Jew and Bedouin women with recent GDM in the Negev area.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
Délai: Determination of HOMA after one year.
The metabolic parameters included glucose and insulin levels, to enable calculations of HOMA IR. (Homeostasis Model Assessment of Insulin Resistance).
Determination of HOMA after one year.
Change in HOMA.
Délai: Detrmination of HOMA after two years.
HOMA calculations post partum.
Detrmination of HOMA after two years.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Determinations of blood lipids .
Délai: Post partum lipids levels after one year.
Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.
Post partum lipids levels after one year.
Change in lipids levels after two years post partum.
Délai: 2 years after delivery.
Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
2 years after delivery.
Post partum BMI changes.
Délai: one year after delivery.
BMI assessments after one year.
one year after delivery.
BMI changes after delivery.
Délai: Two years after delivery.
BMI assessments after delivery.
Two years after delivery.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2007

Achèvement primaire (Réel)

1 mars 2010

Achèvement de l'étude (Réel)

1 avril 2010

Dates d'inscription aux études

Première soumission

22 novembre 2011

Première soumission répondant aux critères de contrôle qualité

28 novembre 2011

Première publication (Estimation)

29 novembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

29 novembre 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 novembre 2011

Dernière vérification

1 novembre 2011

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner