Assessment of Nutritional Status After Gastric Bypass Surgery

Assessment of Nutritional Status and Vitamin Deficiencies in Obese Subjects After Gastric Bypass Surgery

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)

Study Overview

• Status: Completed
• Conditions: Obesity; Nutritional Deficiencies
• Intervention / Treatment: Procedure: Roux-en-Y gastric bypass (RYGP)

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, CH-1011
    • Clinical Research Centre, CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

16 female obese subjects on a waiting list for gastric bypass bariatric surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

• GI tract diseases
• endocrine diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in daily dietary protein intake	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	measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in total energy intake	changes in 24-hour 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	measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
changes in basal metabolic rate	BMR will be measured by indirect calorimetry over a 45-90 min period	measurements obtained baseline , and 3, 6, 12, 36 months after surgery
changes in total energy intake	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	measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in fasting, resting respiratory exchange ratio	measurement will be obtained by indirect calorimetry	measurements obtained baseline, and 3, 6, 12, and 36 months after RYGP
changes in 24-hour urinary urea excretion	24-hour urine collections	Measurements obtained baseline , and 3, 6, 12, 36 months after RYGP

Collaborators and Investigators

• Sponsor: University of Lausanne
• Investigators: Principal Investigator: Vittorio Giusti, MD, CHUV

Publications and helpful links

General Publications

• Giusti V, Theytaz F, Di Vetta V, Clarisse M, Suter M, Tappy L. Energy and macronutrient intake after gastric bypass for morbid obesity: a 3-y observational study focused on protein consumption. Am J Clin Nutr. 2016 Jan;103(1):18-24. doi: 10.3945/ajcn.115.111732. Epub 2015 Dec 16.
• De Giorgi S, Campos V, Egli L, Toepel U, Carrel G, Cariou B, Rainteau D, Schneiter P, Tappy L, Giusti V. Long-term effects of Roux-en-Y gastric bypass on postprandial plasma lipid and bile acids kinetics in female non diabetic subjects: A cross-sectional pilot study. Clin Nutr. 2015 Oct;34(5):911-7. doi: 10.1016/j.clnu.2014.09.018. Epub 2014 Sep 26.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Estimate): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Obesity; Nutritional status; Energy balance; Gastric bypass; Protein balance
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 39/08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No