Clinical trial NCT01891591: Assessment of Nutritional Status After Gastric Bypass Surgery
Official title: Assessment of Nutritional Status and Vitamin Deficiencies in Obese Subjects After Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Nutritional Deficiencies
Keywords: Obesity
Gastric bypass
Energy balance
Nutritional status
Protein balance
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 16 female obese subjects on a waiting list for gastric bypass bariatric surgery

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)


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* GI tract diseases
* endocrine diseases

Primary outcomes:
measure: changes in daily dietary protein intake
timeFrame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
Secondary outcomes:
measure: changes in total energy intake
timeFrame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
measure: changes in basal metabolic rate
timeFrame: measurements obtained baseline , and 3, 6, 12, 36 months after surgery
measure: changes in total energy intake
timeFrame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
Other outcomes:
measure: changes in fasting, resting respiratory exchange ratio
timeFrame: measurements obtained baseline, and 3, 6, 12, and 36 months after RYGP
measure: changes in 24-hour urinary urea excretion
timeFrame: Measurements obtained baseline , and 3, 6, 12, 36 months after RYGP
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Research Centre, CHUV
Study officials:
affiliation: CHUV
name: Vittorio Giusti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.