NCT01595945

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
terminated

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

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

May 9, 2012

Last Update Submit

February 4, 2015

Conditions

Obesity

Keywords

Caloric restrictionObesityGastric bypassResting metabolic rate

Outcome Measures

Primary Outcomes (1)

  • Resting metabolic rate

    24 weeks

Secondary Outcomes (4)

  • Body composition (muscle mass, fat mass)

    24 weeks

  • Body Mass Index

    24 weeks

  • Caloric restriction

    24 weeks

  • Weight loss

    24 weeks

Study Arms (2)

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

Gastric bypassPROCEDURE

Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.

Gastric bypass
Caloric restrictionBEHAVIORAL

Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.

Caloric restriction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Barmherzige Schwestern Vienna

Vienna, 1060, Austria

Location

KiloCoach e.U.

Vienna, 1060, Austria

Location

MeSH Terms

Conditions

Obesity

Interventions

Gastric BypassCaloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresDiet TherapyNutrition TherapyEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Rosa Aspalter, MD.

    KiloCoach e.U.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

AU(2)