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

This study has been terminated.
(Not enough patients in the follow-up period)
Sponsor:
Collaborators:
University of Copenhagen
European Foundation for the Study of Diabetes
Novo Nordisk A/S
Information provided by (Responsible Party):
Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00625040
First received: February 19, 2008
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Obesity
Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Incretin effect before and one year after gastric banding in obese patients without diabetes [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GLP-1 and GIP response curves [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

p-glucose, p-glucagon, p-GLP1, p-GIP, p-cpeptid, p-insulin, p-paracetamol, buffy coat, urine, whole blood sampels


Enrollment: 10
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625040

Locations
Denmark
Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
University of Copenhagen
European Foundation for the Study of Diabetes
Novo Nordisk A/S
Investigators
Principal Investigator: Katrine Bagge Hansen, MD Glostrup Hospital
Study Director: Filip K Knop, MD, PhD Gentofte Hospital
Study Director: Steen Larsen, MD, DMSc Glostrup Hospital
Study Director: Jens Juul Holst, MD,DMSc University of Copenhagen
Study Chair: Viggo Kristensen, MD Glostrup Hospital
  More Information

No publications provided

Responsible Party: Katrine Bagge Hansen, MD, Ph.d, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00625040     History of Changes
Other Study ID Numbers: GB-INK
Study First Received: February 19, 2008
Last Updated: October 8, 2014
Health Authority: Denmark: National Board of Health; Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Incretin effect
Gastric banding
Glucagon
Glucagon-Like Peptide 1
Gastric Inhibitory Peptide
Glucose Intestinal Peptide
Insulin
C-peptide

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014