NCT03407833Enrolling by invitation
Physiologic and Functional Adaptations of Insulin Sensitive Tissues
Physiologic and Functional Adaptations of Insulin Sensitive Tissues After Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 4 Jan 2018
- Start date
- 13 Feb 2018
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity
- NCT number
- NCT03407833
What you commit to
- Study type: Observational
- Planned participants: 500
- From 13 Feb 2018 to the primary completion date, 29 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous lap band surgery
- Previous lap band, sleeve gastrectomy, or gastric bypass surgery
- Established organ dysfunction
- Additional exclusion criteria for patients undergoing liver transplantation:
- Previous lap band, sleeve gastrectomy, or gastric bypass surgery
Other illness
- Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) and celiac sprue.
- Malabsorptive syndromes
- Established renal disease
- Additional exclusion criteria for patients undergoing bariatric surgery:
- Alpha 1 anti-trypsin disease, Wilson's disease, viral hepatitis, alcoholic liver disease
Age
- Recent history of malignancy (\<5 years ago)
- Recent history of malignancy (\< 5 years ago)
Other
- Smoking \>7 cigarettes per day
- Pregnant or breastfeeding
- Additional exclusion criteria for patients undergoing endoscopy/colonoscopy:
Who the study is looking for
- \- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.