Clinical trial NCT00625040: Incretin Physiology and Beta-cell Function Before and After Weight-loss
Official title: Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Incretin effect
Gastric banding
Glucagon
Glucagon-Like Peptide 1
Gastric Inhibitory Peptide
Glucose Intestinal Peptide
Insulin
C-peptide
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: European Foundation for the Study of Diabetes
name: Novo Nordisk A/S
First posted: 2008-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cases and controls are recruited from The Bariatric Clinic at Glostrup Hospital

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.

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

Primary outcomes:
measure: Incretin effect before and one year after gastric banding in obese patients without diabetes
timeFrame: One year
Secondary outcomes:
measure: GLP-1 and GIP response curves
timeFrame: One year
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Katrine Bagge Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte Hospital
name: Filip K Knop, MD, PhD
role: STUDY_DIRECTOR
affiliation: Glostrup University Hospital, Copenhagen
name: Steen Larsen, MD, DMSc
role: STUDY_DIRECTOR
affiliation: University of Copenhagen
name: Jens Juul Holst, MD,DMSc
role: STUDY_DIRECTOR
affiliation: Glostrup University Hospital, Copenhagen
name: Viggo Kristensen, MD
role: STUDY_CHAIR
References: