Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients (FORBES)

This study is currently recruiting participants.
Verified December 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01483768
First received: November 30, 2011
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal iron absorption of morbid obese subjects.

Control of intestinal absorption of iron is mediated by hepcidin, which is expressed in adipose tissue and that its expression is increased in morbidly obese subjects. The working hypothesis is that this increase could explain the high prevalence of systemic iron depletion observed in obese patients.

Main objective: Assess the impact of the decrease in fat mass induced by surgery in obese patients on the intestinal absorption of iron (evaluated by measuring the expression of iron transporters in the duodenum)


Condition Intervention
Obesity
Iron Deficiency
Procedure: Sleeve gastrectomy for morbid obesity

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Impact of Bariatric Surgery by Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The intestinal absorption of iron [ Time Frame: Time Frame 1 year (Time point(s) at which outcome measure is assessed): ] [ Designated as safety issue: No ]
    The intestinal absorption of iron will be assessed by the level of expression of iron transporters (DMT1 and ferroportin) mRNA level by RT-qPCR and at the protein level by Western blot.


Estimated Enrollment: 83
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A:
Sleeve gastrectomy for morbid obesity
Procedure: Sleeve gastrectomy for morbid obesity
Sleeve gastrectomy or longitudinal gastrectomy for morbid obesity: is a partial gastrectomy without interruption of the gastric continuity. This procedure includes the resection of the great curvature of the stomach, the fundus , except the lesser curvature and the antrum.
Other Name: Longitudinal gastrectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbid obese women selected for bariatric surgery

Exclusion Criteria:

  • non obese patients, less than 18 years old, haematological disease with need of blood transfusions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483768

Contacts
Contact: Simon MSIKA, MD, Ph D 01.47.60.63.94 ext + 33 simon.msika@lmr.aphp.fr

Locations
France
Hôpital Louis Mourier Recruiting
Colombes, Ile de France, France, 92701
Contact: Simon MSIKA, MD, Ph D    01.47.60.63.94 ext + 33    simon.msika@lmr.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Simon MSIKA, MD, Ph D Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01483768     History of Changes
Other Study ID Numbers: AOR 10083
Study First Received: November 30, 2011
Last Updated: December 31, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sleeve gastrectomy
Obesity surgery
Iron deficiency
HEPCIDINE

Additional relevant MeSH terms:
Obesity
Anemia, Iron-Deficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014