- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03407833
Physiologic and Functional Adaptations of Insulin Sensitive Tissues
Physiologic and Functional Adaptations of Insulin Sensitive Tissues After Bariatric Surgery
Study Overview
Status
Conditions
Detailed Description
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)
- During the metabolic and bariatric surgical procedures, biopsy of the jejunum, liver and omentum (visceral adipose) may be obtained. Biopsies of skeletal muscle and subcutaneous adipose will be taken at the sites of trocar placement for laparotomy.
- Blood will be collected from an IV placed in the arm used for administering anesthesia required for the indicated procedure.
- Feces will be self-collected by the patient using a provided culture swab specimen container or FOB card.
Liver transplantation (subset)
• Tissue will be collected from excised disease liver
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese, surgery
Obese subjects recruited from the Center for Surgical Weight loss who are undergoing weight loss surgery as part of their standard of care.
Tissue biopsies, blood, and fecal swabs will be collected at surgical visits.
|
Biopsy of the liver is standard of care for diagnosing NAFLD.
Biopsy of omentum, skeletal muscle and subcutaneous adipose (the latter two tissues taken at the site of trocar placement) will be collected intraoperatively at the time of Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG).
The mixed meal tolerance test (MMTT) shows how much insulin your body is making after drinking a liquid meal beverage that contains fats, protein and carbohydrates (sugar).
Glucose, C-peptide, free fatty acids, triglycerides, incretins, pancreatic polypertide, bile aceis, and fatty acid amides can also be measured.
A total of 9 tablespoons of blood is taken over a 255 minute period.
|
Obese, nonsurgery
Obese subjects recruited from the Vanderbilt Endoscopy Clinic who are undergoing upper endoscopy or colonoscopy as part of their standard of care.
Tissue biopsies, blood, and fecal swabs will be collected at day of procedure.
|
Tissue samples will be collected from the jejunum, duodenum, and colon during the subject's standard of care procedure.
|
Lean control
Lean control subjects recruited from the Vanderbilt Endoscopy Clinic who are undergoing upper endoscopy or colonoscopy as part of their standard of care.
Tissue biopsies, blood, and fecal swabs will be collected at day of procedure.
|
Tissue samples will be collected from the jejunum, duodenum, and colon during the subject's standard of care procedure.
|
Liver transplant
Lean or obese subjects who are undergoing liver transplantation as part of their standard of care.
Excised liver tissue will be collected the day of procedure.
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Tissue will be collected from the excised liver for research after the diseased liver has been removed as part of the standard of care procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to establish organoid cultures
Time Frame: 12 months
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Measure percent success rate of making organoid cultures from tissue biopsies
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Charles Flynn, Ph.D., Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171845
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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