Assessment of Nutritional Status After Gastric Bypass Surgery

Completed

• Conditions: Obesity; Nutritional Deficiencies
• Interventions: Procedure: Roux-en-Y gastric bypass (RYGP)

• Registration Number: NCT01891591
• Lead Sponsor: University of Lausanne

Brief Summary

This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake of various common dietary protein sources 16 female patients with BMI \> 40 kg/m2 and on a waiting list for bariatric surgery will be included. The following measurements will be performed before, and 1, 3, 6, 12, and 36 months after RYGP

* body weight

* body composition (bio impedancemetry)

* basal metabolic rate (open circuit indirect calorimetry)

* 24-hour urinary urea excretion

* fasting blood chemistry

* energy and macronutrient's intake (3-day dietary recall)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-07-02
• Last Update Submitted: 2013-07-02
• Study First Posted: 2013-07-03
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• age 18-65 years
• gender: females
• body mass index >35 kg/m2

Exclusion Criteria

• GI tract diseases
• endocrine diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese female subjects	Roux-en-Y gastric bypass (RYGP)	16 obese female subjects with BMI \> 40 kg/m2 on a waiting list for bariatric surgery

Primary Outcome Measures

Name	Time	Method
changes in daily dietary protein intake	measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery	changes in 24-hour protein intake will be evaluated by 7-day food diary; portion size will be assessed with the use of photographs from the SU.VI.MAX study

Secondary Outcome Measures

Name	Time	Method
changes in total energy intake	measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery	Changes in daily total energy intake will be evaluated by 7-day food diary; portion size will be assessed with the use of photographs from the SU.VI.MAX study
changes in basal metabolic rate	measurements obtained baseline , and 3, 6, 12, 36 months after surgery	BMR will be measured by indirect calorimetry over a 45-90 min period

Trial Locations

Locations (1)

Clinical Research Centre, CHUV; 🇨🇭 Lausanne, Switzerland