Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT03407833
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-18
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiologic and Functional Adaptations of Insulin Sensitive Tissues
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Physiologic and Functional Adaptations of Insulin Sensitive Tissues After Bariatric Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: