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
  Purpose

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.


Condition Intervention
Obesity
Procedure: Gastric bypass
Behavioral: Caloric restriction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects

Further study details as provided by KiloCoach e.U.:

Primary Outcome Measures:
  • Resting metabolic rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: April 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gastric bypass
Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate.
Procedure: Gastric bypass
Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.
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.
Behavioral: Caloric restriction
Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595945

Locations
Austria
Hospital Barmherzige Schwestern Vienna
Vienna, Austria, 1060
KiloCoach e.U.
Vienna, Austria, 1060
Sponsors and Collaborators
KiloCoach e.U.
Hospital Barmherzige Schwestern Vienna
Investigators
Study Director: Rosa Aspalter, MD. KiloCoach e.U.
  More Information

Additional Information:
No publications provided

Responsible Party: KiloCoach e.U.
ClinicalTrials.gov Identifier: NCT01595945     History of Changes
Other Study ID Numbers: KCKBHS-01
Study First Received: May 9, 2012
Last Updated: February 4, 2015
Health Authority: Austria: Ethikkommission

Keywords provided by KiloCoach e.U.:
Caloric restriction
Obesity
Gastric bypass
Resting metabolic rate

ClinicalTrials.gov processed this record on May 21, 2015