Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

28 november 2011 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

180

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 43 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Diagnosis of gestational diabetes.

Exclusion Criteria:

  • Diabetes Mellitus

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Post GDM follow-up group.
Every several months the women had instructions and checkups.
Andra namn:
  • Jew and Bedouin women with recent GDM in the Negev area.
Experimentell: 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.
Andra namn:
  • Jew and Bedouin women with recent GDM in the Negev area.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
Tidsram: 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.
Tidsram: Detrmination of HOMA after two years.
HOMA calculations post partum.
Detrmination of HOMA after two years.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Determinations of blood lipids .
Tidsram: 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.
Tidsram: 2 years after delivery.
Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
2 years after delivery.
Post partum BMI changes.
Tidsram: one year after delivery.
BMI assessments after one year.
one year after delivery.
BMI changes after delivery.
Tidsram: Two years after delivery.
BMI assessments after delivery.
Two years after delivery.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2007

Primärt slutförande (Faktisk)

1 mars 2010

Avslutad studie (Faktisk)

1 april 2010

Studieregistreringsdatum

Först inskickad

22 november 2011

Först inskickad som uppfyllde QC-kriterierna

28 november 2011

Första postat (Uppskatta)

29 november 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 november 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 november 2011

Senast verifierad

1 november 2011

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera