Assessment of Nutritional Consequences of Sleeve Gastrectomy (ERNEST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01475903
First received: April 18, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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 Intervention
Obesity
Procedure: Longitudinal sleeve gastrectomy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Nutritional Consequences of Sleeve Gastrectomy

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • micro nutritional status of patients undergoing sleeve gastrectomy [ Time Frame: at 3, 6, 12, 18 and 24 months after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • physical composition measured by impedancemetry [ Time Frame: at 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • arterial blood pressure [ Time Frame: at 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • HOMA test [ Time Frame: at 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • lipid assessment [ Time Frame: at 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • arthropathy estimated clinically [ Time Frame: at 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • questionnaire SF-36 [ Time Frame: at 6 months after the operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

defined population

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475903

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Julie LEGER-GUIST'HAU, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01475903     History of Changes
Other Study ID Numbers: CHU-0093, 2010-A00406-33
Study First Received: April 18, 2011
Last Updated: November 17, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Obesity
Sleeve gastrectomy
Nutritional impact
Vitamin deficiency

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014