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

October 8, 2014 updated by: Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Glostrup Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: One year
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB-INK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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