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

February 21, 2020 updated by: Azienda Ospedaliera Universitaria Integrata Verona

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37126
        • AOUI Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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').
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
Time Frame: 1 month and 12 months
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.
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.
Time Frame: 1 month and 12 months
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 and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
high pressure liquid chromatography (HPLC) method
1 month and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera Universitaria Integrata Verona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universita di Verona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MGZenti MMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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