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

NCT01483768 | Completed DMC

• 1 other identifier: AOR 10083
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Obesity; Iron Deficiency

Keywords

Sleeve gastrectomy; Obesity surgery; Iron deficiency; HEPCIDINE

Outcome Measures

Primary Outcomes (1)

• The intestinal absorption of iron

  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.

  Time Frame 1 year (Time point(s) at which outcome measure is assessed):

Study Arms (1)

Arm A:

EXPERIMENTAL

Sleeve gastrectomy for morbid obesity

Procedure: Sleeve gastrectomy for morbid obesity

Interventions

Sleeve gastrectomy for morbid obesity PROCEDURE

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.

Also known as: Longitudinal gastrectomy

Arm A:

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• morbid obese women selected for bariatric surgery

You may not qualify if:

• non obese patients, less than 18 years old, haematological disease with need of blood transfusions

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Louis Mourier

Colombes, Île-de-France Region, 92701, France

Location

MeSH Terms

Conditions

Obesity; Iron Deficiencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon MSIKA, MD, Ph D

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 1, 2011
• Study Start: September 25, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

FR (1)