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

• ClinicalTrials.gov Identifier: NCT01855386
• Recruitment Status: Terminated
• First Posted: May 16, 2013
• Last Update Posted: November 8, 2018
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment
Gestational Diabetes Mellitus in Pregnancy	Other: Subjects with Gestational Diabetes; Other: Controls without Gestational Diabetes

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 126 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Non-Alcoholic Fatty Liver Disease in Gestational Diabetes - An Opportunity for Prevention of Type 2 Diabetes Mellitus?
• Actual Study Start Date: January 2013
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: September 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Subjects with Gestational Diabetes; Subjects with a history of Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.	Other: Subjects with Gestational Diabetes; Subjects with a history of Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.; Other Names: Gestational Diabetes; Liver ultrasound; blood pressure; blood samples
Controls without Gestational Diabetes; Matched control subjects without Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.	Other: Controls without Gestational Diabetes; Matched control subjects without gestational diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.; Other Names: Liver ultrasound; blood pressure; blood samples

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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

Contacts and Locations

Locations

United States, Florida

Shands Medical Plaza

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Maryam Sattari, MD; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01855386
• Other Study ID Numbers: IRB201600437; 375-2012 ( Other Identifier: University of Florida )
• First Posted: May 16, 2013
• Last Update Posted: November 8, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Pregnancy in Diabetics; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Digestive System Diseases; Pregnancy Complications; Liver Extracts; Hematinics