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Sponsored by: |
BC Women's Hospital & Health Centre |
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Information provided by: | BC Women's Hospital & Health Centre |
ClinicalTrials.gov Identifier: | NCT00849849 |
Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a history of GDM vary widely depending on the length of follow up and the underlying risk of diabetes in the population. Like DM2, the incidence of postpartum diabetes appears to be increasing The cumulative incidence of DM2 varied from 2.6 to > 70% in studies with postpartum follow-up ranging from 6 weeks to 28 years. Among women with a history of gestational diabetes, it is generally accepted that race, age, parity, family history of diabetes, pre-pregnancy weight, postpartum obesity, and weight gain are risk factors for developing DM2. Other suspected risk factors include smoking, physical inactivity, diet, and drugs that adversely affect glucose metabolism. Despite the high and increasing rate of DM2 in Louisiana, the medical community does not have reliable estimates of the number of woman living in southern Louisiana who develop diabetes subsequent to GDM. At Woman's Hospital, the investigators had 8246 deliveries in 2007; 7873 mothers (95% of deliveries) were either African American or Caucasian. Of this group of women, 665 were diagnosed with gestational diabetes mellitus. Thus, around 8.5% of the African American and Caucasian women delivering babies at Woman's Hospital in 2007 had a glucose abnormality. The incidence of diabetes and impaired glucose metabolism in the immediate postpartum period and within 12 months after delivery in this population is unknown. There are no long-term studies performed in Louisiana that have compared the benefits of different screening strategies or evaluated an optimum testing frequency after GDM to reduce the rate of DM2 and cardiovascular disease (CVD) in these high-risk women. The investigators plan to use this study as an outreach effort to provide screening for previous gestational diabetic mothers without adequate medical coverage following delivery.
Condition |
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Diabetes Mellitus, Type 2 |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Comprehensive Postpartum Screening Strategies for Women With Prior Gestational Diabetes (COPSS - GDM): Now is the Time for a Paradigm Shift in Clinical Practice |
Blood samples for diabetes testing
Estimated Enrollment: | 100 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2011 |
Groups/Cohorts |
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Postpartum GDM OGTT
100 women with prior GDM in their index pregnancies will undergo postpartum screening assessment. This program will follow these women who are at a high risk of developing DM2 after delivery for 1 year.
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Women with previous gestational diabetes constitute an ideal group for the development, testing, and implementation of clinical strategies for primary diabetes prevention. One-third to one-half of women with a history of GDM will develop type 2 (DM2) within 3-5 years and 70% will develop DM2 if followed >10 years.
Studies have shown that measuring only the fasting glucose level postpartum is not sufficiently sensitive to identify all women who have impaired glucose tolerance (IGT) or DM2. Data presented at the Fifth International Workshop-Conference on GDM indicated that, postpartum, only 34% of the women with IGT or DM2 had impaired fasting glucose and that 44% of those with DM2 had fasting levels below 100 mg/dl (<5.5 mmol/l). The recommended process to detect permanent diabetes in women who have had GDM and who might become pregnant again is a 75-g 2-h oral glucose tolerance test (OGTT) 6-12 weeks post partum and every year thereafter. Postpartum management of women with GDM is critical because of their markedly increased risk of DM2 and its comorbidities in the future Follow-up studies of women with GDM are necessary to establish the most efficient and most-effective approach to postpartum screening for type 2 diabetes. This study will examine the diagnostic effectiveness of OGTT-derived glucose tolerance, insulin secretion and insulin sensitivity indices compared with indices derived from fasting values of glucose and insulin in subjects with GDM performed post-partum. We will establish whether post-partum fasting and/or glucose-stimulated indices of insulin sensitivity and secretion most accurately estimate the degree of insulin resistance relative to ß-cell function in all race/ethnicity groups of women after delivery of a pregnancy complicated by gestational diabetes and predict their risk for development of diabetes and CVD.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Postpartum women with GDM (before 12 weeks postpartum)
Inclusion Criteria:
Exclusion Criteria (Medical):
Exclusion Criteria (Psychiatric and Behavioral):
Other Exclusion Criteria:
Contact: Donna Shaler | 225 231-5275 | Donna.Shaler@womans.org |
United States, Louisiana | |
Woman's Hospital Research Institute | Recruiting |
Baton Rouge, Louisiana, United States, 70815 | |
Principal Investigator: Karen E Elkind-Hirsch, MSc,PhD | |
Sub-Investigator: Martha Paterson, MD | |
Sub-Investigator: Beverly Ogden, MD |
Principal Investigator: | Karen E Elkind-Hirsch, MSc,PhD | Woman's Health Research Institute |
Responsible Party: | Woman's Health Research Institute ( Dr Karen Elkind-Hirsch, Scientific Director ) |
Study ID Numbers: | RO-08-11 |
Study First Received: | February 23, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00849849 History of Changes |
Health Authority: | United States: Institutional Review Board |
postgestational diabetes diabetes mellitus OGTT insulin sensitivity insulin secretion |
Pregnancy Complications Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Diabetes, Gestational Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Pregnancy Complications Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Diabetes, Gestational Glucose Metabolism Disorders |