The Effect of Gastric Bypass Surgery on Gut Hormones Rela... | NCT01700686

Studies
The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.

NCT01700686

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Dec 17, 2014Estimated

Enrollment

18Actual

Phase

Not provided

Conditions

Obesity
Bone Loss

Interventions

Meal test and dexa scan

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

Dec 2014

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

Oct 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Oct 2, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 4, 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

Dec 16, 2014

Last Update Posted Date

Dec 17, 2014Estimated

Name	Class
Zealand University Hospital	OTHER

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 overall purpose is to explore the link between the gut and the bones by investigating meal stimulated changes in the blood level of a number of hormones and markers related to intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric bypass). The hormones will be measured in blood samples taken before and after surgery. The results are compared with changes in body weight and body composition as measured by DEXA scanning.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese subjects		Meal test and dexa scan	Other: Meal test and dexa scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meal test and dexa scan	Other	Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meal stimulated changes in gut hormones and bone markers.		Before surgery and 4 weeks and 6 months after surgery.

Secondary Outcomes

Measure	Description	Time Frame
Changes in bone mass and body composition.		Before surgery and 6 months after surgery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasians fulfilling the criteria for laparoscopic gastric bypass.
BMI>40kg/m2.

Exclusion Criteria:

Pregnancy
Chronic obstructive pulmonary disease
Diabetes mellitus
Chronic inflammatory bowel disease
Major psychiatric disorder
Drug abuse

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

Subjects are recruited from The Bariatric Clinic, The Hospital of Roskilde-Koege, The University of Copenhagen.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bolette Hartmann, PhD	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of Roskilde-Koege, The University of Copenhagen		Koege		DK-4600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D001851	Bone Diseases, Metabolic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided