ObesityPhase 4NCT01094054
Adjustable Gastric Banding and Its Effects on Postprandial Glucose Metabolism Independent of Weight Loss
A Phase 4 study testing Adjustable gastric banding and Dietary and lifestyle modification in people with Obesity and Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
The overall aim is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead to the development of novel interventions for the prevention and treatment of Type 2 diabetes and obesity. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- What is being tested?
- Adjustable gastric banding and Dietary and lifestyle modification
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2013
- Phase
- Phase 4
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects less than 30 years of age or who are on insulin will not be studied to minimize the possibility of type 1 diabetes.
- Subjects older than 65 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.
- Healthy status will indicate that the participant has no known active systemic illness and no history of microvascular or macrovascular complications of their diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The overall aim is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead to the development of novel interventions for the prevention and treatment of Type 2 diabetes and obesity.
Read the detailed description
The overall aim of this application is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Very often, resolution of diabetes occurs in the early post-operative period prior to the development of significant weight loss. It has been suggested that bariatric surgery alters insulin action but few studies have examined insulin secretion or postprandial glucose fluxes in such patients. At the present time, little is known about how the various bariatric surgical procedures alter glucose homeostasis. It is essential that the effect of bariatric surgery and meal size on these parameters be understood and accurately measured. Enteroendocrine secretion is affected by the rate of intestinal delivery of calories and may also be modulated by the enteric nervous system and the rate of direct delivery of nutrients to enteroendocrine cells. Direct measurement of intestinal transit is also an important part of understanding how bariatric surgery alters intestinal secretion of hormones that may alter glucose metabolism. The Oral and C-peptide Minimal Models when applied to C-peptide, glucose and insulin concentrations after ingestion of a standard labeled mixed meal can accurately measure insulin secretion and action. Subsequently, the disposition index provides a measurement of the appropriateness of insulin secretion for the prevailing insulin action. When coupled with established triple-tracer methodology, a mixed meal can be used to measure fasting and postprandial glucose fluxes. The present experiments will determine the mechanism of glucose lowering after adjustable gastric banding (AGB). AGB seems to be superior to medical therapy in type 2 diabetes. However, bariatric surgery was not compared to intensive efforts at weight reduction which itself ameliorates diabetes and cardiovascular risk. It is therefore unknown if the beneficial effects of AGB on glucose metabolism are related to weight-loss per se rather than a direct effect of AGB.
- Being tested
- Adjustable gastric banding, Dietary and lifestyle modification
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable gastric bandingProcedure or surgery
Placement of adjustable gastric band - laparoscopically
Dietary and lifestyle modificationBehavioural
Dietary and lifestyle modification
Subjects will meet with a dietitian and a psychologist on a weekly basis and consume a diet matched to that of the banding arm
| Study group | Role | What they receive |
|---|---|---|
| Dietary and lifestyle modification | Active comparator | Patients in this arm will eat meals that are identical in size and caloric composition to those consumed by participants in the other arm who undergo adjustable gastric banding Receives: Behavioral: Dietary and lifestyle modification |
| Adjustable gastric banding | Experimental | Subjects will undergo gastric banding as per clinical practice Receives: Procedure: Adjustable gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposition Index
Insulin sensitivity which measures the overall ability of insulin to stimulate glucose disposal and inhibit glucose production will be calculated from plasma glucose and insulin concentrations using the "oral" glucose minimal model. Beta-cell responsivity indices will be calculated using plasma glucose and C-peptide concentrations using the oral C-peptide minimal model. The appropriateness of insulin secretion for the prevailing degree of insulin action is assessed by calculating the total disposition index (DItotal), which equals the product of insulin secretion and insulin sensitivity.
Measured: Change compared to baseline 12 weeks after intervention
Secondary outcomes (1)
Gastric emptying and intestinal transit
Measured: change compared to baseline 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Vella, Mayo Clinic
- Investigators
- Adrian Vella, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094054
- Sponsor's protocol ID
- 09-008460
- Status last verified
- May 2013
- First submitted
- 24 Mar 2010
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sathananthan M, Shah M, Edens KL, Grothe KB, Piccinini F, Farrugia LP, Micheletto F, Man CD, Cobelli C, Rizza RA, Camilleri M, Vella A. Six and 12 Weeks of Caloric Restriction Increases beta Cell Function and Lowers Fasting and Postprandial Glucose Concentrations in People with Type 2 Diabetes. J Nutr. 2015 Sep;145(9):2046-51. doi: 10.3945/jn.115.210617. Epub 2015 Aug 5.
PubMed 26246321
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustable Gastric Banding and Its Effects on Postprandial Glucose Metabolism Independent of Weight Loss
- ClinicalTrials.gov ID
- NCT01094054
- Acronym / sponsor ID
- 09-008460
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Mar 2010 (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.
The overall aim is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead to the development of novel interventions for the prevention and treatment of Type 2 diabetes and obesity.
Detailed description
The overall aim of this application is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Very often, resolution of diabetes occurs in the early post-operative period prior to the development of significant weight loss. It has been suggested that bariatric surgery alters insulin action but few studies have examined insulin secretion or postprandial glucose fluxes in such patients. At the present time, little is known about how the various bariatric surgical procedures alter glucose homeostasis. It is essential that the effect of bariatric surgery and meal size on these parameters be understood and accurately measured. Enteroendocrine secretion is affected by the rate of intestinal delivery of calories and may also be modulated by the enteric nervous system and the rate of direct delivery of nutrients to enteroendocrine cells. Direct measurement of intestinal transit is also an important part of understanding how bariatric surgery alters intestinal secretion of hormones that may alter glucose metabolism. The Oral and C-peptide Minimal Models when applied to C-peptide, glucose and insulin concentrations after ingestion of a standard labeled mixed meal can accurately measure insulin secretion and action. Subsequently, the disposition index provides a measurement of the appropriateness of insulin secretion for the prevailing insulin action. When coupled with established triple-tracer methodology, a mixed meal can be used to measure fasting and postprandial glucose fluxes. The present experiments will determine the mechanism of glucose lowering after adjustable gastric banding (AGB). AGB seems to be superior to medical therapy in type 2 diabetes. However, bariatric surgery was not compared to intensive efforts at weight reduction which itself ameliorates diabetes and cardiovascular risk. It is therefore unknown if the beneficial effects of AGB on glucose metabolism are related to weight-loss per se rather than a direct effect of AGB.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary and lifestyle modification | Active comparator | Behavioral: Dietary and lifestyle modificationPatients in this arm will eat meals that are identical in size and caloric composition to those consumed by participants in the other arm who undergo adjustable gastric banding |
| Adjustable gastric banding | Experimental | Procedure: Adjustable gastric bandingSubjects will undergo gastric banding as per clinical practice |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Subjects less than 30 years of age or who are on insulin will not be studied to minimize the possibility of type 1 diabetes.
- Subjects older than 65 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.
- Healthy status will indicate that the participant has no known active systemic illness and no history of microvascular or macrovascular complications of their diabetes.
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 |
|---|---|---|
| Adjustable gastric bandingPlacement of adjustable gastric band - laparoscopically | Procedure or surgery | Adjustable gastric banding |
| Dietary and lifestyle modificationDietary and lifestyle modification Subjects will meet with a dietitian and a psychologist on a weekly basis and consume a diet matched to that of the banding arm | Behavioural | Dietary and lifestyle modification |
Primary outcome
Disposition Index
Time frame: Change compared to baseline 12 weeks after intervention
Insulin sensitivity which measures the overall ability of insulin to stimulate glucose disposal and inhibit glucose production will be calculated from plasma glucose and insulin concentrations using the "oral" glucose minimal model. Beta-cell responsivity indices will be calculated using plasma glucose and C-peptide concentrations using the oral C-peptide minimal model. The appropriateness of insulin secretion for the prevailing degree of insulin action is assessed by calculating the total disposition index (DItotal), which equals the product of insulin secretion and insulin sensitivity.
1 secondary outcome
Gastric emptying and intestinal transit
Time frame: change compared to baseline 12 weeks after intervention
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 10 May 2013.
- Derived from this study: PubMed 26246321Sathananthan M, Shah M, Edens KL, Grothe KB, Piccinini F, Farrugia LP, Micheletto F, Man CD, Cobelli C, Rizza RA, Camilleri M, Vella A. Six and 12 Weeks of Caloric Restriction Increases beta Cell Function and Lowers Fasting and Postprandial Glucose Concentrations in People with Type 2 Diabetes. J Nutr. 2015 Sep;145(9):2046-51. doi: 10.3945/jn.115.210617. Epub 2015 Aug 5.
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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.
Adrian Vella, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adjustable gastric banding and Dietary and lifestyle modification in people with Obesity and Diabetes, run by Mayo Clinic at 1 site in United States.
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 0 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 10 May 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Disposition Index (time frame: Change compared to baseline 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01094054, which also lists 1 linked publication.
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 10 May 2013.