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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00625040
• Other study ID #: GB-INK
• Status: Terminated
• Phase: N/A
• First received: February 19, 2008
• Last updated: October 8, 2014
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: October 2014
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health; Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate
OGTT: The test is performed with 50 g of glucose deluded in 300 ml water Isoglycemic iv. clamp: Iv. glucose infusion mimicking the glucose response curves from the OGTT Liquid Meal test: The test is performed with 100g of formula milk deluded in 300 ml. water Gastric Emptying Rate: Paracetamol absorption test.

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Glostrup

Sponsors (4)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	European Foundation for the Study of Diabetes, Novo Nordisk A/S, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incretin effect before and one year after gastric banding in obese patients without diabetes		One year	No
Secondary	GLP-1 and GIP response curves		One year	No