Assessment of Nutritional Consequences of Sleeve Gastrectomy

NCT01475903 | Unknown

• 2 other identifiers: CHU-00932010-A00406-33
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Sleeve gastrectomy; Nutritional impact; Vitamin deficiency

Outcome Measures

Primary Outcomes (1)

• micro nutritional status of patients undergoing sleeve gastrectomy

  at 3, 6, 12, 18 and 24 months after intervention

Secondary Outcomes (6)

• physical composition measured by impedancemetry

  at 3, 6, 12, 18 and 24 months

• arterial blood pressure

  at 3, 6, 12, 18 and 24 months

• HOMA test

  at 3, 6, 12, 18 and 24 months

• lipid assessment

  at 3, 6, 12, 18 and 24 months

• arthropathy estimated clinically

  at 3, 6, 12, 18 and 24 months

Study Arms (1)

sleeve gastrectomy

Procedure: Longitudinal sleeve gastrectomy

Interventions

Longitudinal sleeve gastrectomy PROCEDURE

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

sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

defined population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Obesity; Avitaminosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Deficiency Diseases; Malnutrition

Study Officials

• Julie LEGER-GUIST'HAU, MD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

FR (1)