Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients (FORBES)
This study is not yet open for participant recruitment.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01483768
First received: November 30, 2011
Last updated: July 25, 2012
Last verified: July 2012
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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 | Not yet 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: | July 25, 2012 |
| 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 June 17, 2013