Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy

NCT ID: NCT02282475

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-12-31

Brief Summary

Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. This study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during pregnancy.

Detailed Description

This study aims to serially evaluate liver and visceral fat stores during pregnancy and their relationship with glucose and lipid metabolism, placental function, and newborn size. To do this we will conduct both a prospective cohort study of pregnant women without pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at 32-36 weeks gestation and a case-control study of women with normal and impaired glucose tolerance in the early third trimester. Physical assessments will be performed by the Oregon Health and Science University bio-nutrition unit and will include the use of magnetic resonance imaging, ultrasound, and blood draws.

Conditions

Pregnancy; Gestational Diabetes; Obesity; Liver Fat

Study Design

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

Study Groups

Cohort study of pregnant women

Participants will complete the following at 12-16 weeks gestation and again at 32-36 weeks gestation:

1. Fasting glucose, insulin and insulin sensitivity testing;

2. Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism;

3. Measurements of body fat using air displacement technology and MRI;

4. Ultrasound to measure placental blood flow, visceral fat thickness (12-16 weeks only) and to estimate fetal weight (32-36 weeks only);

5. 24 hour diet recalls

6. Questionaires regarding activity level

No interventions assigned to this group

Case-control study Gestational Diabetes

Participants diagnosed with gestational diabetes (cases) and without gestational diabetes (controls) will complete the following at 32-36 weeks gestation:

1. Fasting glucose, insulin and insulin sensitivity testing;

2. Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism;

3. Measurements of body fat by using air displacement technology and MRI;

4. Ultrasound to measure placental blood flow and to estimate fetal weight;

5. 24 hour diet recalls

6. Questionaires regarding activity level

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Pregnant and enrolled members of Kaiser

Exclusion Criteria

• Women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease.
• Non-English speaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Vesco, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Other Identifiers

1R01DK098707-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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