Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients (FORBES)
|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.|
|ClinicalTrials.gov Identifier: NCT01483768|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : April 4, 2018
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 or disease||Intervention/treatment||Phase|
|Obesity Iron Deficiency||Procedure: Sleeve gastrectomy for morbid obesity||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Impact of Bariatric Surgery by Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients|
|Actual Study Start Date :||September 25, 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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
- The intestinal absorption of iron [ Time Frame: Time Frame 1 year (Time point(s) at which outcome measure is assessed): ]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.
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 ClinicalTrials.gov identifier (NCT number): NCT01483768
|Hôpital Louis Mourier|
|Colombes, Ile De France, France, 92701|
|Principal Investigator:||Simon MSIKA, MD, Ph D||Assistance Publique - Hôpitaux de Paris|