NCT00625040

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

February 19, 2008

Last Update Submit

October 8, 2014

Conditions

Obesity

Keywords

Incretin effectGastric bandingGlucagonGlucagon-Like Peptide 1Gastric Inhibitory PeptideGlucose Intestinal PeptideInsulinC-peptide

Outcome Measures

Primary Outcomes (1)

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

    One year

Secondary Outcomes (1)

  • GLP-1 and GIP response curves

    One year

Study Arms (1)

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

Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rateOTHER

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.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

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

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Katrine Bagge Hansen, MD

    Glostrup University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • Viggo Kristensen, MD

    Glostrup University Hospital, Copenhagen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DK(1)