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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

January 11, 2013
February 8, 2013
February 2013
December 2015   (final data collection date for primary outcome measure)
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').
Same as current
Complete list of historical versions of study NCT01767441 on ClinicalTrials.gov Archive Site
  • 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').
Same as current
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
Same as current
 
Bariatric Surgeries and Glucose Homeostasis During a Mixed Meal Test
Effects of Bariatric Surgeries on Glucose Homeostasis and Its Determinants During a Mixed Meal Tolerance Test

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum, plasma

Non-Probability Sample

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)
Obesity
  • 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
  • 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
  • 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
  • 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
  • Roux-en-Y-gastric bypass
    morbidly obese subjects undergoing gastric bypass surgery
    Intervention: Procedure: Roux-en-Y-gastric bypass
  • gastric banding
    morbidly obese subjects undergoing laparoscopic adjustable gastric banding
    Intervention: Procedure: laparoscopic adjustable gastric banding
  • sleeve gastrectomy
    morbidly obese subjects undergoing laparoscopic sleeve gastrectomy
    Intervention: Procedure: laparoscopic sleeve gastrectomy
  • control group
    morbidly obese subjects not undergoing bariatric surgery, on diet treatment
    Intervention: Other: diet treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Riccardo C Bonadonna, MD, PHD +390458123115 riccardo.bonadonna@univr.it
Contact: Maria Grazia Zenti, MD +390458123110 mariagrazia.zenti@univr.it
Italy
 
NCT01767441
MGZenti MMT, MMT in bariatric surgeries
Yes
Azienda Ospedaliera Universitaria Integrata Verona
Azienda Ospedaliera Universitaria Integrata Verona
Universita di Verona
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
Azienda Ospedaliera Universitaria Integrata Verona
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP