Changes in Ectopic Fat Following Surgically Induced Weight Loss
Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?
연구 개요
상세 설명
We are looking for volunteers for this study,wich involves 7 visits over a period of 13 months, the first visit taking place about 2 weeks prior to the planned surgery.
Visit 1 - baseline, before starting your pre-operative diet Visit 2 - just before the surgery Visit 3 - around the time your first band inflation occurs Visit 4 - 1 month after the band inflation Visit 5 - 3 months after the first band inflation Visit 6 - 6 months after the first band inflation Visit 7 - 12 months after the first band inflation
At each visit we do the following tests:
- MRS to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
- Frequently sampled intravenous glucose tolerance test - it is a 3.5 hrs test which determines the amount of insulin your body produces and how well your own insulin is being used by the body
- Body measurements (waist, hip circumference), cholesterol panel, liver function tests, HbA1c (to monitor diabetes control), blood pressure, weight.
We also do an oral glucose tolerance test to check for diabetes on 3 occasions: visit 1, visit 5 and at the end, visit 7.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Texas
-
Dallas, Texas, 미국, 75390
- University of Texas Southwestern
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients already scheduled to undergo gastric banding within 1-2 months.
This study does NOT pay for the bariatric surgery, eligible participants must already be scheduled to have the surgery performed by their own physician
설명
Inclusion Criteria:
- Greater than 18 years old
- Fully understanding and willing to undergo study procedures
- Available for follow-up
- Understand and willing to sign informed consent
- Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study
Exclusion Criteria:
- Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
- Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
- History of pancreatic disease other than diabetes
- Regular use of more than 2 alcoholic drinks per day
- Pregnancy
- Non-English speaking
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pancreatic and Liver Triglyceride (Fat) Content
기간: months after the first band inflation
|
Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
|
months after the first band inflation
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ildiko Lingvay, MD, MPH, University of Texas Southwestern Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .