- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02880813
The Effects of Gastric or Duodenal Nutrient Infusion on Food Intake, Obesity and Comorbidities in Obese Individuals
This pilot study will look at whether infusion of nutrients into the duodenum or into the stomach will result in:
- decrease in hunger and food intake
- greater weight loss due to loss of body fat with reductions in waist and hip circumferences
- improvements in other weight-related health conditions such as diabetes, high blood pressure, and high blood triglycerides. Inclusion criteria: 25-60 years old with a BMI of ≥ 30≤55 kg/m2.
Subjects (16 individuals) will be in the study for 12 days and have a dobhoff tube placed at the start of the study. Subjects will visit MCRU daily for 12 days where meals will be provided, and where anthropometric measures, blood work during an oral mixed meal tolerance test (study start and study end), and surveys will be completed. The dobhoff tube will remain in place until the end of the study.
연구 개요
상세 설명
The investigators propose a pilot study to evaluate whether mimicking rapid gastric emptying with duodenal infusion (DI) of nutrients (treatment) compared to gastric infusion (GI) of nutrients (control) over 12 days will result in 1) decrease in caloric intake 2) loss of body weight 3) improvements in comorbidities, particularly glucose metabolism, decrease in blood triglycerides and hypertension and increase in serum bile acids. Individuals eligible for the study will provide written informed consent. A comprehensive health and weight history will be obtained and physical exam obtained. Randomization will be 1:1 to DI vs. GI. There will be 8 individuals per treatment arm. A Dobhoff tube will be placed in each participant from nose either into duodenum (DI) or into stomach (GI). Participants will be allowed to eat three buffet style meals per day at 8.30 am, noon and 4 pm. The food intake will be noted for each meal by the investigators. Participants will note their feelings of hunger, fullness, bloating, nausea, and energy on a visual analogue scale every fifteen minutes for an hour starting at the initiation of the infusion. The placement of the tube (into stomach or duodenum) will be confirmed on day 1, day 6 and day 12 with radiographs. If necessary, fluoroscopy will be used only once during the study on day 1 to adjust the placement of the tube. During the study, the health of the participants will also be monitored and medications (if any) will be adjusted (if required) on a daily basis.
Intervention Group:
For first three days of the study (starting on Day#2), DI with 180 ml of warm saline will be given over 6 to 15 minutes through the Dobhoff tube starting a minute before initiation of each of the meal. For the remaining 7 days of the study, DI with nutrients in the form of 180 ml (266 Kcal) of warm Ensure Complete (Abbott Nutrition, OH) will be given over 6 to 15 minutes starting a minute before initiation of each meal. If they desire, participants will be allowed to eat a snack after the third meal.
Comparison group:
For first three days of the study (starting on Day#2), GI with 180 ml of warm saline will be given over 6 to 15 minutes through the Dobhoff tube starting a minute before initiation of each of the meal. For the remaining 7 days of the infusion part of the study, GI with nutrients in the form of 180 ml (266 Kcal) of warm Ensure Complete (Abbott Nutrition, OH) will be given over 6 to 15 minutes starting a minute before initiation of each meal. If they desire, participants will be allowed to eat a snack after the third meal.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48108
- Michigan Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects between the ages of 25 and 60 years
- with body mass index (BMI) ≥30≤55 kg/m2
Exclusion Criteria:
- significant heart, kidney, liver, gastrointestinal tract (including gastrointestinal reflux disease), autoimmune disorders such as lupus erythematosus, neurological, psychiatric or endocrine disorders (Type 1 diabetes, adrenal, pituitary or uncontrolled thyroid disease), any previous surgeries on gastrointestinal tract, HIV/AIDS, anemia, clotting disorders, cancers other than minor skin cancers.
- individuals taking anti-obesity drugs, or appetite suppressants within the last 2 months.
- Individuals who have already undergone weight loss surgery are excluded.
- Women who intend to get pregnant, pregnant women and women who are nursing
- people who have a history of eating disorder such as bulimia or binge eating, or a history of or current substance abuse (alcohol, marijuana, cocaine, tobacco etc.).
- people who have stopped smoking within the previous 6 months and
- people with weight changes greater than 5 kg (about 11 pounds) within the previous 3 months.
- individuals who plan to move within 1 year.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Gastric
gastric infusion
|
infusion of nutrients
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실험적: Duodenal
Duodenal infusion
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infusion of nutrients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in body weight
기간: 12 days
|
12 days
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Change in body composition
기간: 12 days
|
12 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Amy Rothberg, MD, PhD, University of Michigan
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 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. .
Infusion에 대한 임상 시험
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Massachusetts General HospitalBaxter Healthcare Corporation완전한
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Fondazione Italiana Sindromi Mielodisplastiche-ETSCentro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte종료됨