Status:
ENROLLING_BY_INVITATION
Physiologic and Functional Adaptations of Insulin Sensitive Tissues
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Diabetes
Insulin Resistance
Eligibility:
All Genders
18+ years
Brief Summary
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 hypothes...
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 ...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03407833
Start Date
February 13 2018
End Date
February 1 2028
Last Update
December 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232