Incretin Physiology and Beta-cell Function Before and After Weight-loss

Terminated

• Conditions: Obesity
• Interventions: Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate

• Registration Number: NCT00625040
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in morbidly obese patients and to describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Detailed Description

Morbid obesity represents a serious health issue in Western countries, with a rising incidence and a strong association with increased mortality and serious co-morbidities, such as diabetes. Surgical interventions, such as laparoscopic gastric banding have been developed with the aim of providing a laparoscopic placed device that is safe and effective in generating substantial weight loss. By investigation of the incretin effect, the secretion of GIP and GLP-1, the insulin response and sensitivity and the beta-cell responsiveness to glucose in 10 obese patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-28
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Caucasians without type 2 diabetes mellitus
• Normal OGTT (75 g of glucose) according to WHO's criteria
• Patients fulfilling the criteria for laparoscopic gastric banding
• Normal Hemoglobin
• Informed consent

Exclusion Criteria

• Liver disease (ALAT > 2 x normal level)
• Nephropathy (s-creatinin > 130 µM or albuminuria)
• Relatives (parents/siblings) with T2DM
• Medical treatment witch cannot be stopped for 12 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate	Obese patients without diabetes with a Body Mass Index \> 37 kg/m2

Primary Outcome Measures

Name	Time	Method
Incretin effect before and one year after gastric banding in obese patients without diabetes	One year

Secondary Outcome Measures

Name	Time	Method
GLP-1 and GIP response curves	One year

Trial Locations

Locations (1)

Glostrup Hospital; 🇩🇰 Glostrup, Denmark