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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908973
First Posted: May 27, 2009
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Copenhagen
Novo Nordisk A/S
Information provided by (Responsible Party):
Carsten Dirksen, Hvidovre University Hospital
  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 Carsten Dirksen, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Carsten Dirksen, MD PhD student, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00908973     History of Changes
Other Study ID Numbers: RnonR
First Submitted: May 26, 2009
First Posted: May 27, 2009
Last Update Posted: March 20, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs