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

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

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.

Study Overview

• Status: Terminated
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Shands Medical Plaza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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: blood samples; blood pressure; Gestational Diabetes; Liver ultrasound
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: blood samples; blood pressure; Liver ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with NAFLD and gestational diabetes.	Patients with gestational diabetes will be screened for fatty liver by ultrasound to estimate the prevalence of NAFLD in this population.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Maryam Sattari, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Liver Diseases; Diabetes Mellitus; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes, Gestational; Pregnancy in Diabetics; Hematinics; Liver Extracts
• Other Study ID Numbers: IRB201600437; 375-2012 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No