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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282475
• Other study ID #: 1R01DK098707-01A1
• Status: Completed
• Start date: November 30, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Liver Fat
• Obesity
• Pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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