Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass
NCT ID: NCT02288351
Last Updated: 2016-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-11-30
2015-04-30
Brief Summary
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The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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RYGB with mucosal abnormality on EGD
Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
Mix Nutrient Meal
Before Surgery: Subjects will have a visit where they will have a mixed nutrient stimulation test. They will be asked to fast for 12 hours prior to this visit (except water). During the visit they will drink an 8 ounce mixed nutrient liquid meal in 5 minute intervals over 20 minutes. During this visit a catheter will be placed in a vein in their arm for blood sample collections. A total of 50 ml of blood will be collected, (10 ml before drinking the mixed nutrient drink, at 30 minutes, at 60 minutes, at 90 minutes and 120 minutes after the mixed nutrient drink).
labs
Fasting Plasma Glucose (FPG) and insulin will be added to the standard pre-operative labs.
Biopsy
Intra-operatively: Subjects will undergo a standard laparoscopic Roux-en-Y Gastric Bypass (RYGB). During the surgery a 2cm tissue sample of the Roux limb will be taken by the doctor and frozen.
Second Mix Nutrient Meal
2 months post-operatively a second mixed nutrient stimulation test will be performed following the same process used pre-operatively.
Second biopsy
. Patients will also be scheduled to undergo a second upper endoscopy and a 2cm biopsy of the Roux limb will be taken by the doctor and frozen in liquid nitrogen.
PET/CT
Lastly, subjects will have a positron emission tomography/computed tomography (PET/CT) scan with Fluorodeoxyglucose (FDG) to evaluate the glucose in the Roux limb after surgery.
Interventions
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Mix Nutrient Meal
Before Surgery: Subjects will have a visit where they will have a mixed nutrient stimulation test. They will be asked to fast for 12 hours prior to this visit (except water). During the visit they will drink an 8 ounce mixed nutrient liquid meal in 5 minute intervals over 20 minutes. During this visit a catheter will be placed in a vein in their arm for blood sample collections. A total of 50 ml of blood will be collected, (10 ml before drinking the mixed nutrient drink, at 30 minutes, at 60 minutes, at 90 minutes and 120 minutes after the mixed nutrient drink).
labs
Fasting Plasma Glucose (FPG) and insulin will be added to the standard pre-operative labs.
Biopsy
Intra-operatively: Subjects will undergo a standard laparoscopic Roux-en-Y Gastric Bypass (RYGB). During the surgery a 2cm tissue sample of the Roux limb will be taken by the doctor and frozen.
Second Mix Nutrient Meal
2 months post-operatively a second mixed nutrient stimulation test will be performed following the same process used pre-operatively.
Second biopsy
. Patients will also be scheduled to undergo a second upper endoscopy and a 2cm biopsy of the Roux limb will be taken by the doctor and frozen in liquid nitrogen.
PET/CT
Lastly, subjects will have a positron emission tomography/computed tomography (PET/CT) scan with Fluorodeoxyglucose (FDG) to evaluate the glucose in the Roux limb after surgery.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 65 years of age
3. BMI \> 35kg/m²
4. Diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
Exclusion Criteria
2. Presence of a seizure disorder (GLUT-1 deficiency syndrome)
3. Use of Tricyclic antidepressants
4. Use of tobacco products
18 Years
65 Years
ALL
No
Sponsors
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Society of American Gastrointestinal and Endoscopic Surgeons
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Philip Omotosho, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Other Identifiers
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Pro00054934
Identifier Type: -
Identifier Source: org_study_id