ObesityBASMEALNCT01767441
Bariatric Surgeries and Glucose Homeostasis During a Mixed Meal Test
An observational study of Obesity, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Roux-en-Y-gastric bypass, laparoscopic adjustable gastric banding and laparoscopic sleeve gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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)
Who may be able to join
- 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
Who cannot join
- BMI< 35 kg/m2.
- pregnancy/lactation.
- prior bariatric or gastrointestinal surgery. Malignancies; mental incapacity; unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Roux-en-Y-gastric bypass, laparoscopic adjustable gastric banding, laparoscopic sleeve gastrectomy, diet treatment
- Keywords
- bariatric surgery, gastric bypass, gastric banding, sleeve gastrectomy, weight loss, Type 2 Diabetes mellitus, GLP1, obesity, mixed meal test
- Medical subject headings
- Obesity, Weight Loss, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y-gastric bypassProcedure or surgery
Also called RYGB
Gastric bypass consisted of creation of a 15-20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb
laparoscopic adjustable gastric bandingProcedure or surgery
Also called LAGB
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.
laparoscopic sleeve gastrectomyProcedure or surgery
Also called SG
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
diet treatmentOther
Also called diet
Hypocaloric diet providing a 1000 Kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y-gastric bypass | morbidly obese subjects undergoing gastric bypass surgery Receives: Procedure: Roux-en-Y-gastric bypass | |
| gastric banding | morbidly obese subjects undergoing laparoscopic adjustable gastric banding Receives: Procedure: laparoscopic adjustable gastric banding | |
| sleeve gastrectomy | morbidly obese subjects undergoing laparoscopic sleeve gastrectomy Receives: Procedure: laparoscopic sleeve gastrectomy | |
| control group | morbidly obese subjects not undergoing bariatric surgery, on diet treatment Receives: Other: diet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 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
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').
Measured: 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
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.
Measured: 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.
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').
Measured: 1 month and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Sponsor
- Investigators
- Maria Grazia Zenti, MD, Principal investigator, Division of Endocrinology and Metabolic Diseases, AOUI Verona, ItalyEnzo Bonora, Professor, Study director, Division of Endocrinology and Metabolic Diseases, University Hospital of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767441
- Sponsor's protocol ID
- MGZenti MMT
- Acronym
- BASMEAL
- Status last verified
- Aug 2012
- First submitted
- 11 Jan 2013
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgeries on Glucose Homeostasis and Its Determinants During a Mixed Meal Tolerance Test
- ClinicalTrials.gov ID
- NCT01767441
- Acronym / sponsor ID
- BASMEAL / MGZenti MMT
- Conditions
- Obesity
- Keywords
- bariatric surgery, gastric bypass, gastric banding, sleeve gastrectomy, weight loss, Type 2 Diabetes mellitus, GLP1, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y-gastric bypass | – | Procedure: Roux-en-Y-gastric bypassmorbidly obese subjects undergoing gastric bypass surgery |
| gastric banding | – | Procedure: laparoscopic adjustable gastric bandingmorbidly obese subjects undergoing laparoscopic adjustable gastric banding |
| sleeve gastrectomy | – | Procedure: laparoscopic sleeve gastrectomymorbidly obese subjects undergoing laparoscopic sleeve gastrectomy |
| control group | – | Other: diet treatmentmorbidly obese subjects not undergoing bariatric surgery, on diet treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- BMI< 35 kg/m2.
- pregnancy/lactation.
- prior bariatric or gastrointestinal surgery. Malignancies; mental incapacity; unwillingness or language barriers precluding adequate understanding or cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y-gastric bypassAlso: RYGBGastric bypass consisted of creation of a 15-20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb | Procedure or surgery | Roux-en-Y-gastric bypass |
| laparoscopic adjustable gastric bandingAlso: LAGBGastric 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. | Procedure or surgery | gastric banding |
| laparoscopic sleeve gastrectomyAlso: SGSleeve 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 | Procedure or surgery | sleeve gastrectomy |
| diet treatmentAlso: dietHypocaloric diet providing a 1000 Kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination | Other | control group |
Primary outcome
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').
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Grazia Zenti, MD principal investigator
Division of Endocrinology and Metabolic Diseases, AOUI Verona, Italy
Enzo Bonora, Professor study director
Division of Endocrinology and Metabolic Diseases, University Hospital of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.