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

NCT02282475 | Completed DMC

• 1 other identifier: 1R01DK098707-01A1
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Gestational Diabetes; Obesity; Liver Fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance

  34 weeks gestation

Study Arms (2)

Cohort study of pregnant women

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

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Pregnant and enrolled members of Kaiser

You may not qualify if:

• Women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease.
• Non-English speaker

Sponsors & Collaborators

• Kaiser Permanente: lead
• Oregon Health and Science University: collaborator

MeSH Terms

Conditions

Diabetes, Gestational; Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

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

Study Officials

• Kim Vesco, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 4, 2014
• Study Start: November 30, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share