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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 28, 2014
Last verified: August 2014
  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: September 2016
Estimated Primary Completion Date: March 2016 (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

  Hide Detailed Description

Detailed Description:

Study Rationale a high prevalence of iron deficiency and anemia has recently been characterized in obese patients and may be related to the stage of low-grade systemic inflammation associated with obesity

Control of intestinal absorption of iron is mediated by hepcidin, a small circulating peptide synthesized primarily by the liver. the synthesis of hepcidin is increased in inflammatory condition and very recently it was shown that hepcidin 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 these patients. the use of bariatric surgery is becoming more common to treat severe obesity (BMI above 35 kg / m2)

The sleeve gastrectomy, recently introduced, involves a very significant weight loss. however, its impact on iron deficiency and anemia are not known

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

Secondary objectives:

  • Assess the impact of the decrease in fat mass induced by surgery in obese patients on the concentration of circulating hepcidin.
  • To study the correlation between the level of expression of iron transporters in the duodenum and the plasma concentration of circulating hepcidin
  • Search for a correlation between the level of hepcidin expression in subcutaneous adipose tissue and visceral and concentration of plasma hepcidin before surgery.
  • Evaluate the effects of sleeve gastrectomy surgery on haematological and iron status of obese patients.

Selection criteria for patients:

Inclusion criteria: female subjects, having a body mass index > 40 kg/m2 (or > 35 kg/m2 with comorbidity) justifies a obesity surgery, For whom the indication of obesity surgery has been laid, the collective decision is taken in consultation, as part of care between different specialty (physicians, surgeons, psychiatrists ...)

Non-inclusion criteria strictly less than age 18 years or strictly greater than 60 years, history of bariatric surgery or stomach, hepatic cytolysis (transaminases > 3n) during cancer treatment (radio or chemotherapy treatments) coefficient of transferrin saturation > 45%; known history of any of the following: hematologic disease requiring transfusions, hemochromatosis, Wilson's disease (because of known interference between metabolism of iron and copper), Chronic inflammation; Patient did not receive a medical examination; Patient did not give informed consent in writing, not affiliated with Patient Social Security or CMU ( universal health coverage) (recipient or beneficiary), known pregnancy

Number needed: 83 patients enrolled

Total duration of the study: 39 months

Duration of participation for each patient: 21 months

Duration of inclusion: 18 months

Methods:

Prospective open multicenter study cognitive. 4 visits are planned as part of this research with some specificity for the different centers.

Visit 1: Presentation of the study and obtaining consent. Visit 2: consultation with implementation of a multidisciplinary assessment of duodenal biopsies by gastroscopy, additional laboratory tests and a pregnancy test if necessary.

Visit 3: surgery (sleeve gastrectomy) with adipose tissue biopsies. Visit 4: creation of a consultation with multidisciplinary assessment of duodenal biopsies by gastroscopy and additional laboratory tests.

Examinations required specifically for research: duodenal biopsies, additional laboratory tests, biopsies of adipose tissue and pregnancy test (dipstick) for all premenopausal women (contraceptives or not).

Primary assessment criteria:

The intestinal absorption of iron will be assessed by the level of expression of iron transporters (DMT1 and ferroportin) mRNA (messenger ribonucleic acid) level by RT-qPCR (reverse transcription quantification polymerase chain reaction) and at the protein level by Western blot.

secondary assessment (s) criteria (s) The concentration of hepcidin plasma will be measured by ELISA in adipose tissue, the level of hepcidin expression is quantified by RT-qPCR .

The haematological will assess the presence of anemia (hemoglobin less than 12g/dl) its micro or macrocytic hemolytic and / or regenerative

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 28, 2014
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 August 28, 2014