Skip to main content
OpenTrials
Completed

NCT Number: NCT01480895

Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Dyslipidemias Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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:

  • To determine GDM frequency in Jewish and Bedouin populations in the Negev area in southern Israel.
  • 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.
  • To study whether intervention in life style leads to similar results in both populations.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of gestational diabetes.

Exclusion criteria

  • Diabetes Mellitus

Treatment and study plan

Lifestyle instruction for Jews and Bedouin GDM women.

Behavioral

Every several months the women had instructions and checkups.

Other names: Jew and Bedouin women with recent GDM in the Negev area.

Primary outcomes

  1. Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).

    Time frame: 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).

  2. Change in HOMA.

    Time frame: Detrmination of HOMA after two years.

    HOMA calculations post partum.

Secondary outcomes

  1. Determinations of blood lipids .

    Time frame: Post partum lipids levels after one year.

    Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.

  2. Change in lipids levels after two years post partum.

    Time frame: 2 years after delivery.

    Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.

  3. Post partum BMI changes.

    Time frame: one year after delivery.

    BMI assessments after one year.

  4. BMI changes after delivery.

    Time frame: Two years after delivery.

    BMI assessments after delivery.

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

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

Acronym: GDM

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 29, 2011
Registry last updated
Nov 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.