Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

Obesity Clinical Trial

Official title:

Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01595945
• Other study ID #: KCKBHS-01
• Status: Terminated
• Phase: N/A
• First received: May 9, 2012
• Last updated: February 4, 2015
• Start date: April 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: KiloCoach e.U.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Austria	Hospital Barmherzige Schwestern Vienna	Vienna
Austria	KiloCoach e.U.	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
KiloCoach e.U.	Hospital Barmherzige Schwestern Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting metabolic rate		24 weeks	No
Secondary	Body composition (muscle mass, fat mass)		24 weeks	No
Secondary	Body Mass Index		24 weeks	No
Secondary	Caloric restriction		24 weeks	No
Secondary	Weight loss		24 weeks	No

External Links

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