Physiologic and Functional Adaptations of Insulin Sensitive Tissues After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Ability to establish organoid cultures
研究概览
简要总结
The long-term goal is to understand the mechanisms of intestinal nutrient sensing and signal relays to insulin sensitive tissues (adipose, skeletal muscle, liver) in humans. The investigators hypothesize that human tissue biopsies (from obese surgery and non-surgery subjects as well as lean controls) can be used to understand the molecular mechanisms underlying intestinal nutrient sensing and signal relay in humans. The investigator will obtain tissue specimens from patients during scheduled upper endoscopies, colonoscopies and scheduled metabolic and bariatric surgeries or liver transplantation. A blood sample (4mL) will be obtained concurrent with these procedures. From metabolic and bariatric surgery subjects blood and tissues (liver, adipose, small intestine, omentum, skeletal muscle) can be collected at the time of surgery. From liver transplantation patients, excised liver tissue will be collected. Stool can be obtained preoperatively and at various time points after surgery. Some bariatric surgery subjects will participate in a mixed-meal tolerance test at their pre-operative visit and several post-operative visits to compare the whole-body metabolic alterations following bariatric procedures.
详细描述
Upper endoscopy (subset)
- Intestinal biopsies will be obtained during scheduled upper endoscopy from the mid-duodenum and/or proximal jejunum. In the case that a patient requires an upper endoscopy after metabolic and bariatric surgery, biopsies will be obtained from the mid-jejunum.
- Blood will be collected from an IV placed in the arm used for administering anesthesia required for the indicated procedure.
Colonoscopy (subset)
- Biopsies of the colon will be obtained during scheduled colonoscopy.
- Blood will be collected from an IV placed in the arm used for administering anesthesia required for the indicated procedure.
Metabolic and bariatric surgery (subset)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Scheduled for upper endoscopy, colonoscopy or metabolic and bariatric surgery, or liver transplantation at Vanderbilt University Medical Center.
- •Additional inclusion criteria for individuals scheduled for metabolic and bariatric surgery: Obese, ≥ 40 kg/m2 or ≥ 35 kg/m2 + one comorbidity (type 2 diabetes [fasting blood glucose ≥ 120 mg/dL; HbA1C ≥ 6.5%]; fatty liver disease, hypertension, cardiovascular disease, hyperlipidemia)
- •Additional inclusion criteria for individuals scheduled for liver transplantation: diagnosis of nonalcoholic liver disease or nonalcoholic steatohepatitis
排除标准
- •Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) and celiac sprue.
- •Smoking >7 cigarettes per day
- •Malabsorptive syndromes
- •Pregnant or breastfeeding
- •Additional exclusion criteria for patients undergoing endoscopy/colonoscopy:
- •Recent history of malignancy (<5 years ago)
- •Previous lap band surgery
- •Established renal disease
- •Additional exclusion criteria for patients undergoing bariatric surgery:
- •Previous lap band, sleeve gastrectomy, or gastric bypass surgery
- •Recent history of malignancy (< 5 years ago)
- •Established organ dysfunction
- •Additional exclusion criteria for patients undergoing liver transplantation:
- •Previous lap band, sleeve gastrectomy, or gastric bypass surgery
- •Alpha 1 anti-trypsin disease, Wilson's disease, viral hepatitis, alcoholic liver disease
结局指标
主要结局
Ability to establish organoid cultures
时间窗: 12 months
Measure percent success rate of making organoid cultures from tissue biopsies
次要结局
未报告次要终点
研究者
Charles R. Flynn
Principal Investigator
Vanderbilt University Medical Center