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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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2012-01-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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RYGB
Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.
human ghrelin
0.5-1 pmol/kg.min of human ghrelin administered by IV two times
Hyperinsulinemic/Euglycemic Clamp
Insulin and glucose infusions to measure glucose kinetics.
VSG
Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.
Hyperinsulinemic/Euglycemic Clamp
Insulin and glucose infusions to measure glucose kinetics.
Low Calorie Diet
Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
very low calorie diet
standard very low calorie diet that is prescribed for all RYGB patients after their operation
Hyperinsulinemic/Euglycemic Clamp
Insulin and glucose infusions to measure glucose kinetics.
Interventions
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human ghrelin
0.5-1 pmol/kg.min of human ghrelin administered by IV two times
very low calorie diet
standard very low calorie diet that is prescribed for all RYGB patients after their operation
Hyperinsulinemic/Euglycemic Clamp
Insulin and glucose infusions to measure glucose kinetics.
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 35 kg/m\^2
* Scheduled for bariatric surgery
* Considering bariatric surgery
* Waiting for insurance approval for bariatric surgery
* Currently not considering bariatric surgery, but otherwise eligible
* Enrollment in medical weight loss program
Exclusion Criteria
* Precious malabsorptive or restrictive intestinal surgery
* Pregnant or breastfeeding
* Recent history of neoplasia (5\<years ago)
* Malabsorptive syndromes
* Inflammatory intestinal disease
* Established organ disfunction
* Allergy to acetaminophen
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University
OTHER
Responsible Party
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Naji Abumrad
Professor of Surgery, Chairman Department of Surgery
Principal Investigators
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Naji Abumrad, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069.
Other Identifiers
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#111237
Identifier Type: -
Identifier Source: org_study_id
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