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

Completed

• Conditions: Liver Fat; Gestational Diabetes; Pregnancy; Obesity

• Registration Number: NCT02282475
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Study Start: 2014-11-30
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy	12-16 weeks and 32-36 weeks gestation	We will compare visceral adipose fat and intrahepatic lipid levels in early pregnancy (12-16 weeks gestation) to late pregnancy (32-36 weeks gestation). This will done by comparing changes in accumulation of fat in the visceral adipose tissue, changes in intrahepatic lipid values and changes in total body fat in early and late pregnancy. We will be collecting body composition measurements and utilizing ultrasound and Magnetic Resonance Imaging.

Secondary Outcome Measures

Name	Time	Method
Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance	34 weeks gestation	We will use a matched case-control design with matching for body mass index to compare intrahepatic lipid, visceral adipose tissue, total body fat, and insulin sensitivity among women with gestational diabetes and normal glucose tolerance, as measured at 32-36 weeks gestation.