Bariatric Surgeries and Glucose Homeostasis During a Mixed Meal Test (BASMEAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Azienda Ospedaliera Universitaria Integrata Verona
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier:
NCT01767441
First received: January 11, 2013
Last updated: February 8, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention
Obesity
Procedure: Roux-en-Y-gastric bypass
Procedure: laparoscopic adjustable gastric banding
Procedure: laparoscopic sleeve gastrectomy
Other: diet treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Bariatric Surgeries on Glucose Homeostasis and Its Determinants During a Mixed Meal Tolerance Test

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria Integrata Verona:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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').


Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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').

  • 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 [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
    Beta-cell function will be assessed by a state of art mathematical model applied to glucose and C-peptide curves during a standardized mixed meal. Two main metrics of beta cell function will be derived from modeling: 1) derivative or dynamic control of beta cell function, and 2) proportional or static control of beta cell function.

  • 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. [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
    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').


Other Outcome Measures:
  • change in HbA1c between baseline and 1 or 12 months after undergoing bariatric surgery or being put on low calorie diet. [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
    high pressure liquid chromatography (HPLC) method


Biospecimen Retention:   Samples Without DNA

serum, plasma


Estimated Enrollment: 64
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Roux-en-Y-gastric bypass
morbidly obese subjects undergoing gastric bypass surgery
Procedure: Roux-en-Y-gastric bypass
Gastric bypass consisted of creation of a 15-20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb
Other Name: RYGB
gastric banding
morbidly obese subjects undergoing laparoscopic adjustable gastric banding
Procedure: laparoscopic adjustable gastric banding
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.
Other Name: LAGB
sleeve gastrectomy
morbidly obese subjects undergoing laparoscopic sleeve gastrectomy
Procedure: laparoscopic sleeve gastrectomy
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
Other Name: SG
control group
morbidly obese subjects not undergoing bariatric surgery, on diet treatment
Other: diet treatment
Hypocaloric diet providing a 1000 Kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination
Other Name: diet

Detailed Description:

The effects of different kind of bariatric surgery on glucose homeostasis and its primary determinants (insulin sensitivity and secretion) may differ from one procedure to another. In spite being able to promote improvement/resolution of T2DM, many mechanisms of metabolic action of weight-loss surgery are still unclear. It has been hypothesized that changing the nutrient route through the gut may be a key factor in changing beta cell function and/or insulin sensitivity.

In this study a mixed meal test will be used to assess changes in glucose regulation, beta cell function and incretin bioavailability brought about by different bariatric surgeries in obese patients.

All participants will ingest a standardized mixed meal (163 Kcal; 57% carbohydrate, 33% fat, 22% prot) and will be monitored for 300 minutes thereafter.

Baseline (-20', -10', 0') blood samples will be collected to measure plasma glucose, insulin, C-peptide, incretins and the 13-Carbon-glucose/12-Carbon-glucose (13C-/12C-glucose) ratio (the last one by isotope ratio mass spectrometry).

At time 0', subjects will ingest a standardized mixed meal containing 30 g corn flour and 20 g cheese (parmesan) over 20 minutes. Plasma glucose, insulin, C-peptide, GLP1/GIP and the 13C-/12C-glucose ratio will be assessed at +10', +20', +30', +45', +60', +75', +90', +105', +120', +140', +160', +180', +200', +220', +240', +270', +300'.

Blood samples will be quickly spun at 1500 g at +4°C, plasma/serum will be collected and stored at -80°C.

The 13-Carbon content of maize starch is higher than most of non maize derived sugars. Thus, in individuals on maize and cane sugar free diets, the 13-Carbon/12-Carbon (13C/12C) maize starch ratio is higher (about 10:1000) than the 13C/12C ratio of endogenous glucose derived from glycogenolysis/gluconeogenesis. When these individuals ingest maize starch, the glucose molecules appearing in the systemic circulation which are derived from maize starch will display a 13C-/12C ratio which is identical to maize starch and higher than endogenous glucose. Thus, by measuring the time course of plasma 13C-/12C-glucose ratio, it will be possible to distinguish meal derived glucose from endogenous glucose output (glycogenolysis and gluconeogenesis).

This mixed meal test will be performed before and 1 and 12 months after bariatric surgery. The same tests with the same timing will be performed in a control group of obese patients not undergoing bariatric surgery, being treated with diet only.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • BMI< 35 kg/m2.
  • pregnancy/lactation.
  • prior bariatric or gastrointestinal surgery. Malignancies; mental incapacity; unwillingness or language barriers precluding adequate understanding or cooperation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767441

Contacts
Contact: Riccardo C Bonadonna, MD, PHD +390458123115 riccardo.bonadonna@univr.it
Contact: Maria Grazia Zenti, MD +390458123110 mariagrazia.zenti@univr.it

Locations
Italy
AOUI Verona Recruiting
Verona, Italy, 37126
Contact: Riccardo C Bonadonna, MD, PHD    +390458123115    riccardo.bonadonna@univr.it   
Contact: Maria Grazia Zenti, MD    +390458123110    mariagrazia.zenti@univr.it   
Principal Investigator: Maria Grazia Zenti, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Universita di Verona
Investigators
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
  More Information

No publications provided

Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT01767441     History of Changes
Other Study ID Numbers: MGZenti MMT, MMT in bariatric surgeries
Study First Received: January 11, 2013
Last Updated: February 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona:
bariatric surgery
gastric bypass
gastric banding
sleeve gastrectomy
weight loss
Type 2 Diabetes mellitus
GLP1
obesity
mixed meal test

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014