- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00466882
Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients
Issues Related to the Use of the INAMED LAPBAND SYSTEM to Reduce BMI's in Obese Renal Failure Patients Needing Renal Transplantation: A Pilot Study
연구 개요
상세 설명
The concern of transplant surgeons is that obese patients with high BMI's are more likely to experience post-transplantation complications than age-matched recipients [1]. Nevertheless, the Summa transplant list contains numerous patients with renal failure that have BMI's above 35. These patients are not considered to be "active" transplant candidates because of their obesity and are not eligible to receive a kidney transplant. Dr. Lal counsels these patients that they must lose weight in order to be considered active candidates for transplantation.
Weight loss for obese patients in renal failure is difficult. These patients must undergo hemodialysis three times weekly. Most of these patients do not, or physically cannot, engage in exercise activities. Many of these patients are burdened psychologically, and further behavioral responsibilities related to weight loss may overstress them. Repetitive diets or behavioral therapy in morbidly obese patients prior to transplantation have had disappointing results [2]. Likewise, pharmacological management of obesity in these patients is largely unsuccessful. Noradrenergic appetite suppressants must be restricted because of stimulatory side-effects. Serotonergic agents have cardiovascular and pulmonary complications. Thermogenic agents are minimally effective [2].
The INAMED LAPBAND SYSTEM is an FDA-approved, surgically-placed device marketed to facilitate weight reduction in obese individuals. The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. These adjustments are performed on average 4-5 times during the first year and twice during the second year.
The purpose of this pilot study is to assess the utility of the LAPBAND in facilitating weight loss in obese renal failure patients awaiting transplantation and to document issues related to its use in these patients. The hope is that the LAPBAND will facilitate enough weight loss to reduce the patient's BMI to 35 or below after placement of the LAPBAND. If the patient reaches the intended goal of BMI of 35, they will be placed on the active renal transplant list and will be eligible for transplantation.
A secondary goal of this research is to follow those patients who successfully reach BMI's of 35 or less who are subsequently transplanted to determine any untoward effects of the LAPBAND upon transplantation success
연구 유형
연락처 및 위치
연구 장소
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Ohio
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Akron, Ohio, 미국, 44304
- Summa Health System
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 18 or older
- Hemodialysis patient with BMI between 36 and 42
Exclusion Criteria:
- Patients undergoing peritoneal dialysis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Inamed Lap-Band System
The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning.
The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
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Patient's will be seen in the physician's office one week post surgery and once a month thereafter.
The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND.
This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two years.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weight Loss
기간: 2 years
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Assess weight loss after surgery
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Transplantation Success
기간: 2 years
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Assess possible effects of weight loss surgery on transplantation success
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: John Zografakis, MD, Summa Health System
- 수석 연구원: Tanamay Lal, MD, Summa Health System
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
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
기타 연구 ID 번호
- INAMED
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