Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
Condition: Obesity; Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

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)
    

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: 88 patients enrolled

      Total duration of the study: 54 months

      Duration of participation for each patient: 24 months

      Duration of inclusion: 30 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
    

Intervention name(s): Sleeve gastrectomy for morbid obesity
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Longitudinal gastrectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleeve gastrectomy; Obesity surgery; Iron deficiency; HEPCIDINE