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Assessment of Nutritional Consequences of Sleeve Gastrectomy (ERNEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01475903
Recruitment Status : Unknown
Verified November 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two types of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a purely restrictive reversible procedure, and gastric bypass (GBP), an irreversible procedure, which associates restriction and mild malabsorption. Longitudinal sleeve gastrectomy (LSG) is another bariatric procedure which tends to develop quickly. More recent, this technique is recognized in France by the High Authority of Health since 2008, consisting of fundus and greater curvature resection, removing 75 % the gastric volume, leaving a narrow gastric tube or "sleeve".

Although malabsorption does not occur in most bariatric procedures, micronutrient deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have minor effects on normal physiological digestive processes but could lead to vitamin deficiency secondary to decreased nutrient intake and a tendency towards avoidance of certain types of food due to intolerance. Studies of nutritional complications of bariatric surgery concern essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no longer performed in France. The nutritional impact of LSG remains to be evaluated. To date, data concerning evaluation of nutritional status from patients who underwent LSG are almost non-existent. Considering this type of surgical procedure, the investigators expect to observe essentially a deficiency in vitamin B12 and iron. Indeed, defined as a purely restrictive intervention, LSG consists of gastric fundus resection which is the site of intrinsic factor production, itself necessary for vitamin B12 absorption. Moreover, decrease of hydrochloric acid production and potential vomiting caused by gastric resection can alter iron absorption.

In view of the increasing popularity of this surgical technique, assessment of the nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.

Condition or disease Intervention/treatment
Obesity Procedure: Longitudinal sleeve gastrectomy

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Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Assessment of Nutritional Consequences of Sleeve Gastrectomy
Study Start Date : November 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : May 2015

Group/Cohort Intervention/treatment
sleeve gastrectomy Procedure: Longitudinal sleeve gastrectomy
The main objective of this study is to assess during a 2-year prospective follow-up, the prevalence of nutrient deficiencies in patients undergoing a longitudinal sleeve gastrectomy for morbid obesity

Primary Outcome Measures :
  1. micro nutritional status of patients undergoing sleeve gastrectomy [ Time Frame: at 3, 6, 12, 18 and 24 months after intervention ]

Secondary Outcome Measures :
  1. physical composition measured by impedancemetry [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  2. arterial blood pressure [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  3. HOMA test [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  4. lipid assessment [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  5. arthropathy estimated clinically [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  6. questionnaire SF-36 [ Time Frame: at 6 months after the operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
defined population

Inclusion Criteria:

  • Age between 18 and 65 years
  • Initial BMI = 35
  • Proposition of a sleeve gastrectomy during a multidisciplinary consultation
  • Bariatric surgery procedure carried out at the University Hospital of Clermont- Ferrand.
  • Patient covered by the national health insurance scheme
  • Patient having read, understood and signed the information sheet and the consent form

Exclusion Criteria:

  • History of pathology or major surgical procedure which could interfere with the nutritional state and other study parameters (cancer, DID, digestive pathology, infectious or inflammatory disease)
  • Pregnant or breast-feeding women
  • Existence of cognitive disorders which could interfere with compliance of the study
  • Person deprived of judicial or administrative freedom
  • Participation in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01475903

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Contact: Patrick LACARIN 04 73 75 11 95

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CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Principal Investigator: Julie LEGER-GUIST'HAU, MD University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01475903    
Other Study ID Numbers: CHU-0093
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011
Keywords provided by University Hospital, Clermont-Ferrand:
Sleeve gastrectomy
Nutritional impact
Vitamin deficiency
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight