Clinical Trial: The Role of Non-Alcoholic Fatty Liver Disease in Gestational Diabetes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non-Alcoholic Fatty Liver Disease in Gestational Diabetes - An Opportunity for Prevention of Type 2 Diabetes Mellitus?

Brief Summary: The thought is that Non-Alcoholic Fatty Liver Disease (NAFLD) plays a key role in the progression to prediabetes/T2DM in those with a history of Gestational Diabetes (GDM). The investigators want to know if having a fatty liver will be connected with more glucose abnormalities (higher fasting/oral glucose tolerance test glucose, more insulin resistance) and that a history of GDM will be common in those with NAFLD.

Detailed Summary:

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, pulse, 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 two times after the subject has had her baby (at 6 weeks postpartum, and at 6 months postpartum).

The subject will give blood samples during the 6 weeks postpartum visit and 6 months postpartum visit, and an Oral Glucose Tolerance Test will be done at these visits. Blood samples will be drawn by putting a small needle or IV catheter (a small plastic tube) into a vein in the subject's arm. Blood samples will be obtained at timed intervals both before and after the subject is given a glucose beverage to drink, to see how well the subject's body deals with sugar in the blood over time. The total amount of blood to be drawn for each Oral Glucose Tolerance Test and research blood work will be approximately 90 ml (about 6 tablespoons). The total volume of blood taken over the course of the study for each subject will be approximately 180 ml (about 12 tablespoons).

The subject will have their blood pressure measured with a blood pressure cuff during each clinic 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 6 month postpartum visit. This will take about 30 to 60 minutes each time.

The investigator's study coordinator will call the subject to do a que
Sponsor: University of Florida

Current Primary Outcome: Percentage of patients with NAFLD and gestational diabetes. [ Time Frame: 6 months ]

Patients with gestational diabetes will be screened for fatty liver by ultrasound to estimate the prevalence of NAFLD in this population.


Original Primary Outcome: Percentage of patients with NAFLD and gestational diabetes. [ Time Frame: 12 months ]

Patients with gestational diabetes will be screened for fatty liver by ultrasound to estimate the prevalence of NAFLD in this population.


Current Secondary Outcome: Insulin sensitivity expressed as the Matsuda Index, measured during an oral glucose tolerance test (OGTT). [ Time Frame: At 6 weeks and 6 months after delivery ]

Patients will undergo an OGTT at 6 weeks and 6 months after delivery to measure their insulin sensitivity (which will be expressed as Matsuda Index).


Original Secondary Outcome: Insulin sensitivity expressed as the Matsuda Index, measured during an oral glucose tolerance test. [ Time Frame: At 6 and 12 months after delivery ]

Patients will undergo an OGTT at 6 and 12 months after delivery to measure their insulin sensitivity (which will be expressed as Matsuda Index).


Information By: University of Florida

Dates:
Date Received: March 21, 2013
Date Started: January 2013
Date Completion: May 2017
Last Updated: April 27, 2017
Last Verified: April 2017