Clinical trial NCT01855386: The Role of Non-Alcoholic Fatty Liver Disease in Gestational Diabetes
Official title: Non-Alcoholic Fatty Liver Disease in Gestational Diabetes - An Opportunity for Prevention of Type 2 Diabetes Mellitus?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * a pregnant female
* age between 18-50 years.

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 description: 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 questionnaire over the phone at 3 months after the subject has had the baby. During the phone call, the study coordinator will ask the subject how the baby is being fed. The study coordinator will also update information about development of any new medical problems and medications the subject's doctor might have started, activity levels, and health habits. Subjects will be asked questionnaires to update this information during their 6 week postpartum and 6 month postpartum clinic visits as well.

The subject's understanding and approval of these procedures is required if she is to participate in this study.

Eligibility criteria: Inclusion Criteria:

* a pregnant female
* age between 18-50 years.

Exclusion Criteria:

* pregravid diabetes mellitus
* inability to understand and speak English
* inability to provide consent
* plans to relocate out of the area within 12 months postpartum

Primary outcomes:
measure: Percentage of patients with NAFLD and gestational diabetes.
timeFrame: 6 months
Secondary outcomes:
measure: Insulin sensitivity expressed as the Matsuda Index, measured during an oral glucose tolerance test (OGTT).
timeFrame: At 6 weeks and 6 months after delivery
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Medical Plaza
state: Florida
Study officials:
affiliation: University of Florida
name: Maryam Sattari, MD
role: PRINCIPAL_INVESTIGATOR
References: