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?
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32608
- Shands Medical Plaza
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- a pregnant female
- age between 18-50 years.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
다른 이름들:
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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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of patients with NAFLD and gestational diabetes.
기간: 6 months
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Patients with gestational diabetes will be screened for fatty liver by ultrasound to estimate the prevalence of NAFLD in this population.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insulin sensitivity expressed as the Matsuda Index, measured during an oral glucose tolerance test (OGTT).
기간: At 6 weeks and 6 months after delivery
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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).
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At 6 weeks and 6 months after delivery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maryam Sattari, MD, University of Florida
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB201600437
- 375-2012 (기타 식별자: University of Florida)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Subjects with Gestational Diabetes에 대한 임상 시험
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University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern... 그리고 다른 협력자들완전한