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

Kaiser Permanente logo

Kaiser Permanente

Status

Completed

Conditions

Gestational Diabetes
Obesity
Liver Fat
Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT02282475
1R01DK098707-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

78 participants in 2 patient groups

Cohort study of pregnant women
Description:
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
Case-control study Gestational Diabetes
Description:
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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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