Physiologic and Functional Adaptations of Insulin Sensitive Tissues
NCT ID: NCT03407833
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
500 participants
OBSERVATIONAL
2018-02-13
2028-02-29
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Surgical biopsy
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).
Mixed-meal tolerance test
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.
Endoscopy biopsy
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.
Endoscopy biopsy
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.
Excised Liver Tissue Sampling
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.
Interventions
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Endoscopy biopsy
Tissue samples will be collected from the jejunum, duodenum, and colon during the subject's standard of care procedure.
Surgical biopsy
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).
Mixed-meal tolerance test
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.
Excised Liver Tissue Sampling
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Smoking \>7 cigarettes per day
* Malabsorptive syndromes
* Pregnant or breastfeeding
* Recent history of malignancy (\<5 years ago)
* Previous lap band surgery
* Established renal disease
* Previous lap band, sleeve gastrectomy, or gastric bypass surgery
* Recent history of malignancy (\< 5 years ago)
* Established organ dysfunction
* Previous lap band, sleeve gastrectomy, or gastric bypass surgery
* Alpha 1 anti-trypsin disease, Wilson's disease, viral hepatitis, alcoholic liver disease
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Charles R. Flynn
Principal Investigator
Principal Investigators
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Charles Flynn, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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171845
Identifier Type: -
Identifier Source: org_study_id