Gut Hormone Response, Appetite and Intestinal Transit Tim... | NCT00908973

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

NCT00908973

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

46Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

May 26, 2009

First Submission Date that Met QC Criteria

May 26, 2009

First Posted Date

May 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Name	Class
University of Copenhagen	OTHER
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carsten Dirksen, MD	Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology at Hvidovre University Hospital		Hvidovre	Copenhagen	DK-2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided