Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

This study has been terminated.
Sponsor:
Collaborator:
Hospital Barmherzige Schwestern Vienna
Information provided by (Responsible Party):
KiloCoach e.U.
ClinicalTrials.gov Identifier:
NCT01595945
First received: May 9, 2012
Last updated: February 4, 2015
Last verified: February 2015

May 9, 2012
February 4, 2015
April 2012
February 2015   (final data collection date for primary outcome measure)
Resting metabolic rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01595945 on ClinicalTrials.gov Archive Site
  • Body composition (muscle mass, fat mass) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Caloric restriction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
  • Procedure: Gastric bypass
    Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.
  • Behavioral: Caloric restriction
    Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.
  • Gastric bypass
    Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate.
    Intervention: Procedure: Gastric bypass
  • Caloric restriction
    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.
    Intervention: Behavioral: Caloric restriction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01595945
KCKBHS-01
No
KiloCoach e.U.
KiloCoach e.U.
Hospital Barmherzige Schwestern Vienna
Study Director: Rosa Aspalter, MD. KiloCoach e.U.
KiloCoach e.U.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP