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The Role of Non-Alcoholic Fatty Liver Disease (NAFLD) in Gestational Diabetes (GDM) – An Opportunity for Prevention of Type 2 Diabetes Mellitus

PStudy Name: Non-Alcoholic Fatty Liver Disease in Gestational Diabetes

Principal Investigator: Maryam Sattari, M.D.

Phone: (352)-265-0651

Email: maryam.sattari@medicine.ufl.edu

What is the Non-Alcoholic Fatty Liver Disease in Gestational Diabetes study?

This study is a collaborative effort between General Internal Medicine, Endocrinology, Obstetrics, and the Clinical and Translational Science Institute at University of Florida. Specifically it explores the role non-alcoholic fatty liver disease (NAFLD) plays in development of postpartum glucose metabolism abnormalities in patients with gestational diabetes. The information made available through this study may help scientists to develop novel treatments and new strategies to prevent diseases.

Who can participate?

Pregnant females, who have been diagnosed with gestational diabetes and who are currently between 18 and 50 years and meet additional study criteria are eligible.

What do I have to do as a participant?

Eligible participants will visit UF Health Shands Medical Plaza in Gainesville, Florida.

A liver ultrasound will be completed during the last trimester of pregnancy along with a questionnaire. The questionnaire includes baseline maternal characteristics, age, race, ethnicity, parity, blood pressure, medications, activity level, sociodemographic and behavioral risk factors, pregravid BMI, previous obstetric history, medical and family history.

The subject will come in person to clinic three times after the subject has had their baby (6 weeks, 6 months, and 12 months after childbirth) The Subject will give blood samples during the 6 weeks postpartum visit and 12 months postpartum visit. The blood will be drawn by putting a needle into a vein in the subject’s arm. Each time, one small tube of blood will be taken. This will take about five minutes. The Investigators anticipate that the total volume of blood taken over the course of study from each subject will be around 110 milliliters.

The subject will have their blood pressure measured with a blood pressure cuff during each visit. The height, weight and pulse rate will also be measured. This will take about five minutes.

The subject will have an ultrasound of her liver at the 6 week postpartum visit and 12 month postpartum visit. This will take about 30 to 60 minutes.

The subject’s understanding and approval of these procedures is required if they are to participate in this study.

The investigator’s study coordinator will call the subject twice: 3 months and 9 months after the subject has had the baby. During each phone call, the study coordinator will ask the subject how the baby is being fed. The investigators will also update information about development of any new medical problems and medications the subject’s doctor might have started.

Additional Information:

http://clinicaltrials.gov/ct2/show/NCT01855386