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

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ClinicalTrials.gov Identifier: NCT00625040
Recruitment Status : Terminated (Not enough patients in the follow-up period)
First Posted : February 28, 2008
Last Update Posted : October 9, 2014
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

Tracking Information
First Submitted Date February 19, 2008
First Posted Date February 28, 2008
Last Update Posted Date October 9, 2014
Study Start Date January 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2014)
Incretin effect before and one year after gastric banding in obese patients without diabetes [ Time Frame: One year ]
Original Primary Outcome Measures
 (submitted: February 26, 2008)
Incretin effect before and one year after gastric banding in obese patients with type 2 diabetes compared with obese patients without diabetes [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT00625040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 26, 2008)
GLP-1 and GIP response curves [ Time Frame: One year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incretin Physiology and Beta-cell Function Before and After Weight-loss
Official Title Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
p-glucose, p-glucagon, p-GLP1, p-GIP, p-cpeptid, p-insulin, p-paracetamol, buffy coat, urine, whole blood sampels
Sampling Method Non-Probability Sample
Study Population The cases and controls are recruited from The Bariatric Clinic at Glostrup Hospital
Condition Obesity
Intervention 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.

Study Groups/Cohorts A
Obese patients without diabetes with a Body Mass Index > 37 kg/m2
Intervention: Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 8, 2014)
10
Original Estimated Enrollment
 (submitted: February 26, 2008)
20
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00625040
Other Study ID Numbers GB-INK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
Study Sponsor Glostrup University Hospital, Copenhagen
Collaborators
  • University of Copenhagen
  • European Foundation for the Study of Diabetes
  • Novo Nordisk A/S
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
PRS Account Glostrup University Hospital, Copenhagen
Verification Date October 2014