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Search / Trial NCT03407833

Physiologic and Functional Adaptations of Insulin Sensitive Tissues

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jan 15, 2018

Trial Information

Current as of July 21, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

  • 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

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Charles Flynn, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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