ObesityNCT01891591
Assessment of Nutritional Status After Gastric Bypass Surgery
An observational study of Obesity and Nutritional Deficiencies, run by University of Lausanne at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity, Nutritional Deficiencies
- What is being tested?
- Roux-en-Y gastric bypass (RYGP)
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 16 female obese subjects on a waiting list for gastric bypass bariatric surgery
Who may be able to join
- age 18-65 years
- gender: females
- body mass index >35 kg/m2
Who cannot join
- GI tract diseases
- endocrine diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Obesity, Nutritional Deficiencies
- Being tested
- Roux-en-Y gastric bypass (RYGP)
- Keywords
- Obesity, Gastric bypass, Energy balance, Nutritional status, Protein balance
- Medical subject headings
- Obesity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass (RYGP)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| obese female subjects | 16 obese female subjects with BMI > 40 kg/m2 on a waiting list for bariatric surgery Receives: Procedure: Roux-en-Y gastric bypass (RYGP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMar 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Vittorio Giusti, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891591
- Sponsor's protocol ID
- 39/08
- Status last verified
- Jun 2013
- First submitted
- 17 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39351881Giusti 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.
PubMed 26675775De 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.
PubMed 25306425
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Status and Vitamin Deficiencies in Obese Subjects After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01891591
- Acronym / sponsor ID
- 39/08
- Conditions
- Obesity, Nutritional Deficiencies
- Keywords
- Obesity, Gastric bypass, Energy balance, Nutritional status, Protein balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese female subjects | – | Procedure: Roux-en-Y gastric bypass (RYGP)16 obese female subjects with BMI > 40 kg/m2 on a waiting list for bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 16 female obese subjects on a waiting list for gastric bypass bariatric surgery
Key inclusion criteria (3 listed)
- age 18-65 years
- gender: females
- body mass index >35 kg/m2
Key exclusion criteria (2 listed)
- GI tract diseases
- endocrine diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass (RYGP) | Procedure or surgery | obese female subjects |
Primary outcome
changes in daily dietary protein intake
Time frame: 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
3 secondary outcomes
changes in total energy intake
Time frame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
changes in basal metabolic rate
Time frame: measurements obtained baseline , and 3, 6, 12, 36 months after surgery
changes in total energy intake
Time frame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Derived from this study: PubMed 39351881Chakhtoura 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.
- Derived from this study: PubMed 26675775Giusti 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.
- Derived from this study: PubMed 25306425De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vittorio Giusti, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Nutritional Deficiencies, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in daily dietary protein intake (time frame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891591, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.