Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incretin effect before and one year after gastric banding in obese patients without diabetes
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Katrine Bagge Hansen
MD, Ph.d
Glostrup University Hospital, Copenhagen