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

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.

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Key information

Conditions

Pregnancy Body Weight Diabetes Mellitus Diabetes, Gestational Digestive System Diseases Endocrine System Diseases Fatty Liver Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Liver Diseases Liver Fat Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

Oregon Health and Science University

Registry information

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Nov 4, 2014
Registry last updated: Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed