Band to Bypass - Metabolism Kinetics in Gastric Bypass an... | NCT01559792

Studies
Band to Bypass - Metabolism Kinetics in Gastric Bypass and Banding

NCT01559792

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Mar 21, 2012Estimated

Enrollment

18Estimated

Phase

Not provided

Conditions

Gastric Bypass
Gastric Banding

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 21, 2012Estimated

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 20, 2012

Last Update Posted Date

Mar 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigators want to study the changes in secretion of gastrointestinal hormones, absorption and metabolism of food and liquids before and after gastric bypass and in patients who are gastric banded but are getting conversion to a gastric bypass. All patients are with normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is faster after gastric bypass and the secretion of gastrointestinal hormones change.

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

18Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal glucose tolerance
Patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass

Exclusion Criteria:

Diabetes,
Study population must undergo gastric bypass

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

all with normal glucose tolerance - patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
siv H Jacobsne, MD	Contact	+4538626357		siv.hesse@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital	Recruiting	Hvidovre		2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26245808	Derived	Bojsen-Moller KN, Jacobsen SH, Dirksen C, Jorgensen NB, Reitelseder S, Jensen JE, Kristiansen VB, Holst JJ, van Hall G, Madsbad S. Accelerated protein digestion and amino acid absorption after Roux-en-Y gastric bypass. Am J Clin Nutr. 2015 Sep;102(3):600-7. doi: 10.3945/ajcn.115.109298. Epub 2015 Aug 5.
23893303	Derived