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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 78

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women ages 18-40 years and actively enrolled in Kaiser Permanente Northwest (KPNW).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort study of pregnant women; Participants will complete the following at 12-16 weeks gestation and again at 32-36 weeks gestation: Fasting glucose, insulin and insulin sensitivity testing;; Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism;; Measurements of body fat using air displacement technology and MRI;; Ultrasound to measure placental blood flow, visceral fat thickness (12-16 weeks only) and to estimate fetal weight (32-36 weeks only);; 24 hour diet recalls; Questionaires regarding activity level
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: Fasting glucose, insulin and insulin sensitivity testing;; Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism;; Measurements of body fat by using air displacement technology and MRI;; Ultrasound to measure placental blood flow and to estimate fetal weight;; 24 hour diet recalls; Questionaires regarding activity level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy	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.	12-16 weeks and 32-36 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance	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.	34 weeks gestation

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Kim Vesco, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: 1R01DK098707-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO