Trial record 1 of 300 for:    gestational diabetes
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Non-Alcoholic Fatty Liver Disease in Gestational Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01855386
First received: March 21, 2013
Last updated: October 13, 2014
Last verified: October 2014
  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: 12 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. [ Time Frame: At 6 weeks and 12 months after delivery ] [ Designated as safety issue: No ]
    Patients will undergo an OGTT at 6 weeks and 12 months after delivery to measure their insulin sensitivity (which will be expressed as Matsuda Index).


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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 12 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 12 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 12 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 12 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, 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 three times after the subject has had their baby (6 weeks, 6 months, and 12 months after childbirth) The Subject will give blood samples during the 6 weeks postpartum visit and 12 months postpartum visit. The blood will be drawn by putting a needle into a vein in the subject's arm. Each time, one small tube of blood will be taken. This will take about five minutes. The Investigators anticipate that the total volume of blood taken over the course of study from each subject will be around 110 milliliters.

The subject will have their blood pressure measured with a blood pressure cuff during each 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 12 month postpartum visit. This will take about 30 to 60 minutes.

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

The investigator's study coordinator will call the subject twice: 3 months and 9 months after the subject has had the baby. During each phone call, the study coordinator will ask the subject how the baby is being fed. The investigators will also update information about development of any new medical problems and medications the subject's doctor might have started.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
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

No publications provided

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: October 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Fatty Liver
Liver Diseases
Pregnancy in Diabetics
Digestive System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Liver Extracts
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014