NCT01891591

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
Last Updated

July 3, 2013

Status Verified

June 1, 2013

Enrollment Period

3.8 years

First QC Date

June 17, 2013

Last Update Submit

July 2, 2013

Conditions

ObesityNutritional Deficiencies

Keywords

ObesityGastric bypassEnergy balanceNutritional statusProtein balance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • changes in total energy intake

    measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

  • changes in basal metabolic rate

    measurements obtained baseline , and 3, 6, 12, 36 months after surgery

  • changes in total energy intake

    measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

Other Outcomes (2)

  • changes in fasting, resting respiratory exchange ratio

    measurements obtained baseline, and 3, 6, 12, and 36 months after RYGP

  • changes in 24-hour urinary urea excretion

    Measurements obtained baseline , and 3, 6, 12, 36 months after RYGP

Study Arms (1)

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)

Interventions

Roux-en-Y gastric bypass (RYGP)PROCEDURE
obese female subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • GI tract diseases
  • endocrine diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre, CHUV

Lausanne, CH-1011, Switzerland

Location

Related Publications (3)

  • Chakhtoura MT, Nakhoul NF, Akl EA, Safadi BY, Mantzoros CS, Metzendorf MI, El-Hajj Fuleihan G. Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery. Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2.

    PMID: 39351881DERIVED

  • 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.

    PMID: 26675775DERIVED

  • 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.

    PMID: 25306425DERIVED

MeSH Terms

Conditions

ObesityMalnutrition

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Vittorio Giusti, MD

    CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of Physiology

Study Record Dates

First Submitted

June 17, 2013

First Posted

July 3, 2013

Study Start

March 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 3, 2013

Record last verified: 2013-06

Locations

CH(1)