Effect of Caloric Restriction and Gastric Bypass on Resti... | NCT01595945

Studies
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

NCT01595945

Sponsor

KiloCoach e.U.

Status

Terminated

Last Update Posted

Feb 5, 2015Estimated

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Gastric bypass
Caloric restriction

Countries

Austria

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

May 9, 2012

First Submission Date that Met QC Criteria

May 9, 2012

First Posted Date

May 10, 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

Feb 4, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Name	Class
Hospital Barmherzige Schwestern Vienna	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

Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. The purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastric bypass	Other	Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate.	Procedure: Gastric bypass
Caloric restriction	Other	Caloric restriction calculated by an online weight management program (based on subject's starting weight, start BMI, age, target weight and time span). Subjects are followed-up in regard to resting metabolic rate.	Behavioral: Caloric restriction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric bypass	Procedure	Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.	Gastric bypass

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting metabolic rate		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Body composition (muscle mass, fat mass)		24 weeks
Body Mass Index		24 weeks
Caloric restriction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI ≥30 kg/m2

Exclusion Criteria:

Marked weight reduction in the last 2 years (>5% of initial body weight)
Recent extreme fasting (during the last month)
Manifest eating disorders (assignment to a specialist for eating disorders)
Severe psychiatric disorders requiring treatment
Pregnancy, lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosa Aspalter, MD.	KiloCoach e.U.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Barmherzige Schwestern Vienna		Vienna		1060	Austria
KiloCoach e.U.

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

Intervention Browse Module

MeSH Terms

ID	Term
D015390	Gastric Bypass
D031204	Caloric Restriction

Ancestor Terms

ID	Term
D050110	Bariatric Surgery
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided