Adjustable Gastric Banding and Its Effects on Postprandial Glucose Metabolism Independent of Weight Loss

NCT ID: NCT01094054

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-01-31

Brief 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.

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.

Conditions

Obesity; Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dietary and lifestyle modification

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

Group Type: ACTIVE_COMPARATOR

Dietary and lifestyle modification

Intervention Type: BEHAVIORAL

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

Adjustable gastric banding

Subjects will undergo gastric banding as per clinical practice

Group Type: EXPERIMENTAL

Adjustable gastric banding

Intervention Type: PROCEDURE

Placement of adjustable gastric band - laparoscopically

Interventions

Adjustable gastric banding

Placement of adjustable gastric band - laparoscopically

Intervention Type: PROCEDURE

Dietary and lifestyle modification

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• We will recruit 20 subjects who have a fasting glucose concentration of 126 mg/dl on two or more occasions or who have a history of type 2 diabetes treated with one or two oral agents other than thiazolidinediones.
• Potential participants will attend the Mayo Clinic Clinical Research Unit (CRU) for a screening visit.
• In addition, the investigators will also recruit 20 subjects with type 2 diabetes, from the Nutrition Clinic who are not interested in pursuing surgical intervention.
• The 2 groups will be matched for age, gender and BMI and duration and severity (HbA1c and no. of oral medications needed to achieve glycemic control) of diabetes.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Adrian Vella

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Vella, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26246321 (View on PubMed)

Other Identifiers

09-008460

Identifier Type: -

Identifier Source: org_study_id