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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01855386
First received: March 21, 2013
Last updated: September 21, 2016
Last verified: September 2016
  Purpose
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 Intervention
Gestational Diabetes Mellitus in Pregnancy
Other: Subjects with Gestational Diabetes
Other: Controls without Gestational Diabetes

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Percentage of patients with NAFLD and gestational diabetes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients with gestational diabetes will be screened for fatty liver by ultrasound to estimate the prevalence of NAFLD in this population.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 190
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855386

Contacts
Contact: Maryam Sattari, MD 352-265-0651

Locations
United States, Florida
Shands Medical Plaza Recruiting
Gainesville, Florida, United States, 32608
Contact: Maryam Sattari, MD    352-265-0651      
Principal Investigator: Maryam Sattari, MD         
Sub-Investigator: Kenneth Cusi, MD         
Sub-Investigator: Robert Egerman, MD         
Sub-Investigator: Anthony Gregg, MD         
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     History of Changes
Other Study ID Numbers: 375-2012 
Study First Received: March 21, 2013
Last Updated: September 21, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
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

ClinicalTrials.gov processed this record on September 29, 2016