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TerminatedNCT00625040Updated Oct 9, 2014

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

An observational study in Obesity, sponsored by Glostrup University Hospital, Copenhagen. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-09.

Sponsored by Glostrup University Hospital, Copenhagen · Observational

Why this study was terminated
Not enough patients in the follow-up period
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Incretin effect
  • Gastric banding
  • Glucagon
  • Glucagon-Like Peptide 1
  • Gastric Inhibitory Peptide
  • Glucose Intestinal Peptide
  • Insulin
  • C-peptide
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 10 is below the median of 92 across 219 observational studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Glostrup University Hospital, Copenhagen is the lead sponsor of 104 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherOral 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.

06

What researchers measure

Primary outcomes

  1. Incretin effect before and one year after gastric banding in obese patients without diabetes

    Time frame: One year

Secondary outcomes

  1. GLP-1 and GIP response curves

    Time frame: One year

07

Study locations

1 site
  • Glostrup Hospital
    Glostrup, 2600, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00625040
Lead sponsor
Glostrup University Hospital, Copenhagen
Collaborators
University of Copenhagen, European Foundation for the Study of Diabetes, Novo Nordisk A/S
Responsible party
Katrine Bagge Hansen (MD, Ph.d, Glostrup University Hospital, Copenhagen) — Principal investigator
First posted
Feb 28, 2008
Start date
Jan 2008
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Oct 9, 2014

Study contacts

Katrine Bagge Hansen, MD
principal investigator · Glostrup University Hospital, Copenhagen
Filip K Knop, MD, PhD
study director · Gentofte Hospital
Steen Larsen, MD, DMSc
study director · Glostrup University Hospital, Copenhagen
Jens Juul Holst, MD,DMSc
study director · University of Copenhagen
Viggo Kristensen, MD
study chair · Glostrup University Hospital, Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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