NCT00908973

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

May 26, 2009

Last Update Submit

March 19, 2012

Conditions

Obesity

Keywords

ObesityGastric bypassGut hormoneIntestinal transit time

Study Arms (3)

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 Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology at Hvidovre University Hospital

Hvidovre, Copenhagen, DK-2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum specimens are retained

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carsten Dirksen, MD

    Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD student

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

DK(1)