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

Gestational Diabetes Mellitus Clinical Trial

— GDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480895
• Other study ID #: SOR452307CTL
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: November 28, 2011
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: November 2011
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Diagnosis of gestational diabetes.

Exclusion Criteria:

• Diabetes Mellitus

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle instruction for Jews and Bedouin GDM women.
Every several months the women had instructions and checkups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).	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.	No
Primary	Change in HOMA.	HOMA calculations post partum.	Detrmination of HOMA after two years.	No
Secondary	Determinations of blood lipids .	Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.	Post partum lipids levels after one year.	No
Secondary	Change in lipids levels after two years post partum.	Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.	2 years after delivery.	No
Secondary	Post partum BMI changes.	BMI assessments after one year.	one year after delivery.	No
Secondary	BMI changes after delivery.	BMI assessments after delivery.	Two years after delivery.	No