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Clinical Trials/NCT02282475
NCT02282475CompletedNot Applicable

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

Kaiser Permanente0 sites78 target enrollmentStarted: November 30, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78
Primary Endpoint
Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy

Study Overview

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy

Time Frame: 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 Outcomes

  • Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance(34 weeks gestation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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