Physiologic and Functional Adaptations of Insulin Sensitive Tissues
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/25/2018 |
| Start Date: | February 13, 2018 |
| End Date: | February 2028 |
Physiologic and Functional Adaptations of Insulin Sensitive Tissues After Bariatric Surgery
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 obese patients during scheduled upper endoscopies, colonoscopies
and scheduled metabolic and bariatric surgeries. The investigator will obtain tissue
specimens from lean patients during scheduled endoscopies and colonoscopies. 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) will
be collected at the time of surgery. Stool will be obtained preoperatively and at various
time points after surgery. A subset of 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.
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 obese patients during scheduled upper endoscopies, colonoscopies
and scheduled metabolic and bariatric surgeries. The investigator will obtain tissue
specimens from lean patients during scheduled endoscopies and colonoscopies. 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) will
be collected at the time of surgery. Stool will be obtained preoperatively and at various
time points after surgery. A subset of 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.
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.
- 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.
Inclusion Criteria:
- Scheduled for upper endoscopy, colonoscopy or metabolic and bariatric surgery at
Vanderbilt University.
- BMI: Lean, 19-25 kg/m2 or Obese, ≥ 35 kg/m2 scheduled for upper endoscopy or
colonoscopy. Obese, ≥ 35 kg/m2 at the time of metabolic and bariatric surgery or any
weight thereafter.
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.
- Gastroenteritis (diarrhea and/or vomiting) or constipation within the past week.
- Smoking >7 cigarettes per day
- Previous malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Recent history of malignancy (<5 years ago)
- Malabsorptive syndromes
- Established organ dysfunction
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Charles Flynn, Ph.D.
Phone: 615-322-6281
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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