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Clinical Trials/NCT00625040
NCT00625040
Terminated
Not Applicable

Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding

Glostrup University Hospital, Copenhagen1 site in 1 country10 target enrollmentJanuary 2008
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
10
Locations
1
Primary Endpoint
Incretin effect before and one year after gastric banding in obese patients without diabetes
Status
Terminated
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
January 2011
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Katrine Bagge Hansen

MD, Ph.d

Glostrup University Hospital, Copenhagen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incretin effect before and one year after gastric banding in obese patients without diabetes

Time Frame: One year

Secondary Outcomes

  • GLP-1 and GIP response curves(One year)

Study Sites (1)

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