Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders After Gastric Bypass (RnonR)

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Novo Nordisk A/S
Information provided by (Responsible Party):
Carsten Dirksen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00908973
First received: May 26, 2009
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

The aim of the study is to describe differences in meal-stimulated gut hormone response, appetite and intestinal transit time between good and poor responders 1-2 years after Gastric Bypass surgery for obesity.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders 1-2 Years After Gastric Bypass

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Biospecimen Retention:   Samples Without DNA

Plasma and serum specimens are retained


Enrollment: 46
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Good responders
Excess weight loss of > 60% 1 year after gastric bypass surgery
Poor responders
Excess weight loss of =< 50% 1 year after gastric bypass surgery
Lean controls
Non-gastric bypass operated lean individuals, matched for age and sex

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Case subjects are recruited from the outpatient clinic of endocrinology at Hvidovre University Hospital. Control subjects are recruited through announcement in local newspapers.

Criteria

Inclusion Criteria:

  • Age 20-60 years
  • Completed laparoscopic gastric bypass surgery without complications (cases)
  • No previous gastric bypass surgery (controls)

Exclusion Criteria:

  • Diabetes
  • Disease or treatment interfering with appetite or gastrointestinal motility
  • Pregnancy or breastfeeding
  • Excess weight loss 1 year after gastric bypass > 50% and =< 60% (cases)
  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: NCT00908973

Locations
Denmark
Department of Endocrinology at Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Novo Nordisk A/S
Investigators
Principal Investigator: Carsten Dirksen, MD Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark
  More Information

No publications provided

Responsible Party: Carsten Dirksen, MD PhD student, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00908973     History of Changes
Other Study ID Numbers: RnonR
Study First Received: May 26, 2009
Last Updated: March 19, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Obesity
Gastric bypass
Gut hormone
Intestinal transit time

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014