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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094054
• Other study ID #: 09-008460
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2010
• Last updated: May 8, 2013
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

• Individuals aged 30 - 65 years seen in the Nutrition Clinic at the Mayo Clinic, are potentially eligible prior to undergoing adjustable gastric banding (AGB).

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Procedure:
• Adjustable gastric banding
Placement of adjustable gastric band - laparoscopically

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change compared to baseline 12 weeks after intervention	No
Secondary	Gastric emptying and intestinal transit		change compared to baseline 12 weeks after intervention	No