The Role of Non-Alcoholic Fatty Liver Disease in Gestational Diabetes
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/10/2018 |
| Start Date: | January 2013 |
| End Date: | September 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
Gainesville, Florida 32608
Principal Investigator: Maryam Sattari, MD
Phone: 352-265-0651
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