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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The cases and controls are recruited from The Bariatric Clinic at Glostrup Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

A; Obese patients without diabetes with a Body Mass Index > 37 kg/m2

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incretin effect before and one year after gastric banding in obese patients without diabetes	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
GLP-1 and GIP response curves	One year

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Collaborators: Novo Nordisk A/S; University of Copenhagen; European Foundation for the Study of Diabetes
• Investigators: Principal Investigator: Katrine Bagge Hansen, MD, Glostrup University Hospital, Copenhagen; Study Director: Filip K Knop, MD, PhD, Gentofte Hospital; Study Director: Steen Larsen, MD, DMSc, Glostrup University Hospital, Copenhagen; Study Director: Jens Juul Holst, MD,DMSc, University of Copenhagen; Study Chair: Viggo Kristensen, MD, Glostrup University Hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): February 28, 2008

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Insulin; Incretin effect; Glucagon-Like Peptide 1; Glucagon; C-peptide; Gastric banding; Gastric Inhibitory Peptide; Glucose Intestinal Peptide
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: GB-INK