Gestational Diabetes MellitusGDMNCT01480895
Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
A study testing Lifestyle instruction for Jews and Bedouin GDM women. in people with Gestational Diabetes Mellitus, run by Soroka University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Lifestyle instruction for Jews and Bedouin GDM women.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of gestational diabetes.
Who cannot join
- Diabetes Mellitus
About this study
Official title: 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.
Read the detailed 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:
- 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Lifestyle instruction for Jews and Bedouin GDM women.
- Keywords
- Diabetes Mellitus Type 2, Gestational Diabetes Mellitus, Glucose Intolerance, Physical exercise, Nutritional Habits, Dyslipidemia
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Glucose Intolerance, Motor Activity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle instruction for Jews and Bedouin GDM women.Behavioural
Also called Jew and Bedouin women with recent GDM in the Negev area.
Every several months the women had instructions and checkups.
| Study group | Role | What they receive |
|---|---|---|
| Post GDM follow-up group. | No intervention | Not described Receives: Behavioral: Lifestyle instruction for Jews and Bedouin GDM women. |
| lifestyle intervention group. | Experimental | The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program. Receives: Behavioral: Lifestyle instruction for Jews and Bedouin GDM women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Determination of HOMA after one year.
Change in HOMA.
HOMA calculations post partum.
Measured: Detrmination of HOMA after two years.
Secondary outcomes (4)
Determinations of blood lipids .
Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.
Measured: Post partum lipids levels after one year.
Change in lipids levels after two years post partum.
Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
Measured: 2 years after delivery.
Post partum BMI changes.
BMI assessments after one year.
Measured: one year after delivery.
BMI changes after delivery.
BMI assessments after delivery.
Measured: Two years after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMar 2007
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Meyerstein, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480895
- Sponsor's protocol ID
- SOR452307CTL
- Acronym
- GDM
- Status last verified
- Nov 2011
- First submitted
- 22 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style
- ClinicalTrials.gov ID
- NCT01480895
- Acronym / sponsor ID
- GDM / SOR452307CTL
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Diabetes Mellitus Type 2, Gestational Diabetes Mellitus, Glucose Intolerance, Physical exercise, Nutritional Habits, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post GDM follow-up group. | No intervention | Behavioral: Lifestyle instruction for Jews and Bedouin GDM women. |
| lifestyle intervention group. | Experimental | Behavioral: Lifestyle instruction for Jews and Bedouin GDM women.The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of gestational diabetes.
Key exclusion criteria (1 listed)
- Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle instruction for Jews and Bedouin GDM women.Also: Jew and Bedouin women with recent GDM in the Negev area.Every several months the women had instructions and checkups. | Behavioural | Post GDM follow-up group., lifestyle intervention group. |
Primary outcome
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).
Change in HOMA.
Time frame: Detrmination of HOMA after two years.
HOMA calculations post partum.
4 secondary outcomes
Determinations of blood lipids .
Time frame: Post partum lipids levels after one year.
Change in lipids levels after two years post partum.
Time frame: 2 years after delivery.
Post partum BMI changes.
Time frame: one year after delivery.
BMI changes after delivery.
Time frame: Two years after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle instruction for Jews and Bedouin GDM women. in people with Gestational Diabetes Mellitus, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance). (time frame: Determination of HOMA after one year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.