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

NCT00687479 | Completed

• 1 other identifier: 05-013
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

insulin sensitivity; insulin secretion; infant outcome

Outcome Measures

Primary Outcomes (1)

• Insulin action measures

  20-30 weeks of pregnancy

Secondary Outcomes (1)

• infant gestational age

  time of delivery

Study Arms (3)

1-NGT

normal glucose tolerance

2-GDM

Gestational Diabetes mellitus

3.GIGT

Gestational Impaired glucose tolerance

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, nondiabetic pregnant African-American and Caucasian women who have been scheduled for a standard 3-hour glucose tolerance test at 24-28 weeks in the Woman's Hospital Pathology laboratory.

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Woman's: lead
• Baton Rouge Area Foundation: collaborator

Study Sites (1)

Woman's Hospital Pathology Laboratory

Baton Rouge, Louisiana, 70815, United States

Location

Related Publications (1)

• 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.

  PMID: 11522706 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for insulin measurements

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Karen E Elkind-Hirsch, Ph.D.

  Woman's Health Research Institute

  PRINCIPAL INVESTIGATOR

• Beverly Ogden, MD

  Woman's Pathology Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: May 30, 2008
• Study Start: January 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)