Insulin Action During Pregnancy in Woman at High Risk for Gestational Diabetes

NCT ID: NCT00687479

Last Updated: 2014-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-12-31

Brief Summary

The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that are potentially linked to complications during pregnancy and to increased risks of obesity and diabetes in later life. The investigators will explore the use of indexes of insulin status to identify the metabolic risk profile of pregnant women which may vary by race. Understanding whether there are differences which vary by race may influence clinical screening and treatment of pregnant women.

Detailed Description

The major goal of our proposed study is to validate a new approach to estimating insulin sensitivity and ß-cell function in African-American women compared to non-Hispanic white women in southern Louisiana who are at a high risk for gestational diabetes mellitus (GDM). We will determine whether the whole body insulin sensitivity index (WBISI) and insulinogenic index (IGI) [derived from an oral glucose tolerance test (OGTT)] can be used during 24-28 weeks of pregnancy to accurately estimate the degree of insulin resistance relative to ß-cell function in women with GDM in those with impaired glucose tolerance (IGT) as well as those who are glucose tolerant. Fasting values will also be assessed using the homeostasis model assessment (HOMA-IR and HOMA-%B) to evaluate insulin resistance and ß-cell function. We will explore the potential use of these measures to define the metabolic risk profile of these pregnant women and compare them with obstetric outcomes. We will determine if there are differences in risk that vary by race. Second, given the high likelihood that women who manifest GDM will develop type 2 diabetes mellitus (DM), identification of these patients by ethnic group or other independent determinants will permit intervention after delivery that might delay or prevent the onset of type 2 DM.

Conditions

Gestational Diabetes Mellitus

Keywords

insulin sensitivity; insulin secretion; infant outcome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1-NGT

normal glucose tolerance

No interventions assigned to this group

2-GDM

Gestational Diabetes mellitus

No interventions assigned to this group

3.GIGT

Gestational Impaired glucose tolerance

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18-42 years of age
• at 20-30 weeks of gestation
• Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism.

Exclusion Criteria

• <18 years or >42 years of age
• non-Caucasian or non-African-American ethnicity
• use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baton Rouge Area Foundation

OTHER

Sponsor Role: collaborator

Woman's

OTHER

Sponsor Role: lead

Responsible Party

Karen Elkind-Hirsch

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen E Elkind-Hirsch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Woman's Health Research Institute

Beverly Ogden, MD

Role: PRINCIPAL_INVESTIGATOR

Woman's Pathology Laboratory

Locations

Woman's Hospital Pathology Laboratory

Baton Rouge, Louisiana, United States

Countries

United States

References

Kirwan JP, Huston-Presley L, Kalhan SC, Catalano PM. Clinically useful estimates of insulin sensitivity during pregnancy: validation studies in women with normal glucose tolerance and gestational diabetes mellitus. Diabetes Care. 2001 Sep;24(9):1602-7. doi: 10.2337/diacare.24.9.1602.

Reference Type: BACKGROUND

PMID: 11522706 (View on PubMed)

Other Identifiers

05-013

Identifier Type: -

Identifier Source: org_study_id