Assessment of Nutritional Status After Gastric Bypass Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891591
• Other study ID #: 39/08
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: July 2, 2013
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2013
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years

• gender: females

• body mass index >35 kg/m2

Exclusion Criteria:

• GI tract diseases

• endocrine diseases

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiencies
• Obesity

Intervention

Procedure:
• Roux-en-Y gastric bypass (RYGP)

Locations

Country	Name	City	State
Switzerland	Clinical Research Centre, CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	changes in 24-hour urinary urea excretion	24-hour urine collections	Measurements obtained baseline , and 3, 6, 12, 36 months after RYGP	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No