Comprehensive Postpartum Screening Strategies for Women With Gestational Diabetes Mellitus (GDM)

NCT00849849 | Completed DMC

• 1 other identifier: RO-08-11
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

postgestational diabetes; diabetes mellitus; OGTT; insulin sensitivity; insulin secretion

Outcome Measures

Primary Outcomes (1)

• Determine best way to assess glucose disorder prevalence in women with prior GDM

  A 2 hr, 75-gram OGTT with measurements of insulin and glucose will be performed at their 6-12 week and 1-year post-delivery check-up; this will be compared with the results of their single fasting glucose and insulin value.

  3 years

Secondary Outcomes (1)

• Investigate if cardiometabolic markers-lipid profile and blood pressure anthropometric markers such as BMI [BMI, absolute body weight]; visceral adiposity as assessed by abdominal girth are associated with an increased diabetes risk

  3 years

Study Arms (1)

Postpartum GDM OGTT

200 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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Postpartum women with GDM (before 12 weeks postpartum)

You may qualify if:

• Postpartum Women (6-12 weeks)who experienced GDM during index pregnancy 18 years to 42 years of age
• English-speaking
• Written consent for participation in the study

You may not qualify if:

• Cholestasis during the past pregnancy
• Serum AST and/or ALT level exceeding more than twice normal laboratory values
• History or clinical manifestation of cardiovascular disease
• History or clinical manifestation of diabetes or use of anti-diabetic drugs before pregnancy
• History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
• Regular use of medications for weight control, psychosis and hormonal birth control
• Current use of medication to treat diabetes
• History or clinical manifestation of any eating disorder
• Individuals who smoke
• History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
• Pregnancy or pregnancy planned during the coming year
• Not willing or unable to adhere to the clinical evaluation schedule over the twelve -month study period

Sponsors & Collaborators

• Woman's: lead

Study Sites (1)

Woman's Hospital Research Institute

Baton Rouge, Louisiana, 70815, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for diabetes testing

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Karen E Elkind-Hirsch, MSc,PhD

  Woman's Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director of Research

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 24, 2009
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)