Bariatric Surgeries and Glucose Homeostasis During a Mixed Meal Test
BASMEAL
Effects of Bariatric Surgeries on Glucose Homeostasis and Its Determinants During a Mixed Meal Tolerance Test
1 other identifier
observational
16
1 country
1
Brief Summary
Bariatric surgery can lead to improvement or even resolution of type 2 diabetes Mellitus (T2DM) with the spectrum of responses depending also on operation procedures. However, many mechanisms of metabolic action of different surgical techniques still are unclear. The aim of this study is to provide a better understanding of the effects of three types of bariatric surgery (lap banding, gastric bypass and sleeve gastrectomy) on beta-cell function and incretin secretion. A mixed meal tolerance (MMT) test will be performed before and 1 and 12 months after surgery to assess beta cell adequacy and glucagon-like-peptide-1 (GLP1)/glucose-dependent insulinotropic polypeptide (GIP) bioavailability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 24, 2020
August 1, 2012
2.8 years
January 11, 2013
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in glucose response (pAUC) to mixed meal test between baseline and 1 month after undergoing bariatric surgery or being put on low calorie diet
Blood samples will be taken at basal (-20',-10' and 0'), and after the ingestion of a standardized mixed meal (+10', +20', +30',+45', +60', +75', +90', +105', +120', +140', +160', +180', +200', +220', +240', +270', +300').
1 month
Secondary Outcomes (3)
change in glucose response (pAUC) to mixed meal test between baseline and 12 months after undergoing bariatric surgery or being put on low calorie diet
12 months
changes in β-cell response mixed meal test between baseline and 1 and 12 months after undergoing bariatric surgery or being put on low calorie diet
1 month and 12 months
changes in active GLP1 systemic bioavailability during a mixed meal test between baseline and 1 or 12 months after undergoing bariatric surgery or being put on low calorie diet.
1 month and 12 months
Other Outcomes (1)
change in HbA1c between baseline and 1 or 12 months after undergoing bariatric surgery or being put on low calorie diet.
1 month and 12 months
Study Arms (4)
Roux-en-Y-gastric bypass
morbidly obese subjects undergoing gastric bypass surgery
gastric banding
morbidly obese subjects undergoing laparoscopic adjustable gastric banding
sleeve gastrectomy
morbidly obese subjects undergoing laparoscopic sleeve gastrectomy
control group
morbidly obese subjects not undergoing bariatric surgery, on diet treatment
Interventions
Gastric bypass consisted of creation of a 15-20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb
Gastric banding functions by limiting food intake after the placement of an inflatable tube around the stomach just below the gastroesophageal junction, which allows for adjustment of the size of the outlet via the addition or removal of saline through a subcutaneous port.
Sleeve gastrectomy involved a gastric reduction of 75 to 80% by resecting the stomach alongside a 30-French endoscope beginning 3 cm from pylorus and ending at the angle of His
Hypocaloric diet providing a 1000 Kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination
Eligibility Criteria
A total of 64 morbidly obese patients will be studied, composed of: * 16 subjects scheduled for Roux-en-Y-gastric bypass; * 16 subjects scheduled for laparoscopic adjustable gastric banding; * 16 subjects scheduled for laparoscopic sleeve gastrectomy; * 16 subjects not undergoing bariatric surgery, on diet treatment (control group)
You may qualify if:
- BMI \> 40 kg/m2.
- BMI ≥ 35 kg/m2 and comorbidities.
- No major organ disease unrelated to excess body weight.
- Mentally able to understand the study and willingness to participate in the study
You may not qualify if:
- BMI\< 35 kg/m2.
- pregnancy/lactation.
- prior bariatric or gastrointestinal surgery. Malignancies; mental incapacity; unwillingness or language barriers precluding adequate understanding or cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOUI Verona
Verona, 37126, Italy
Biospecimen
serum, plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Grazia Zenti, MD
Division of Endocrinology and Metabolic Diseases, AOUI Verona, Italy
- STUDY DIRECTOR
Enzo Bonora, Professor
Division of Endocrinology and Metabolic Diseases, University Hospital of Verona
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2013
First Posted
January 14, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 24, 2020
Record last verified: 2012-08
Data Sharing
- IPD Sharing
- Will not share