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Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

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ClinicalTrials.gov Identifier: NCT01595945
Recruitment Status : Terminated
First Posted : May 10, 2012
Last Update Posted : February 5, 2015
Sponsor:
Collaborator:
Hospital Barmherzige Schwestern Vienna
Information provided by (Responsible Party):
KiloCoach e.U.

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Gastric bypass Behavioral: Caloric restriction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects
Study Start Date : April 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Resting metabolic rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Body composition (muscle mass, fat mass) [ Time Frame: 24 weeks ]
  2. Body Mass Index [ Time Frame: 24 weeks ]
  3. Caloric restriction [ Time Frame: 24 weeks ]
  4. Weight loss [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: KiloCoach e.U.
ClinicalTrials.gov Identifier: NCT01595945     History of Changes
Other Study ID Numbers: KCKBHS-01
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

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