Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT01483768
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2011-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intestinal absorption of iron', 'timeFrame': 'Time Frame 1 year (Time point(s) at which outcome measure is assessed):', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleeve gastrectomy', 'Obesity surgery', 'Iron deficiency', 'HEPCIDINE'], 'conditions': ['Obesity', 'Iron Deficiency']}, 'descriptionModule': {'briefSummary': 'Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal iron absorption of morbid obese subjects.\n\nControl 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.\n\nMain 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)', 'detailedDescription': "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\n\nControl 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\n\nThe 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)\n\nThe sleeve gastrectomy, recently introduced, involves a very significant weight loss. however, its impact on iron deficiency and anemia are not known\n\nmain 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\n\nSecondary objectives:\n\n* Assess the impact of the decrease in fat mass induced by surgery in obese patients on the concentration of circulating hepcidin.\n* To study the correlation between the level of expression of iron transporters in the duodenum and the plasma concentration of circulating hepcidin\n* Search for a correlation between the level of hepcidin expression in subcutaneous adipose tissue and visceral and concentration of plasma hepcidin before surgery.\n* Evaluate the effects of sleeve gastrectomy surgery on haematological and iron status of obese patients.\n\nSelection criteria for patients:\n\nInclusion 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 ...)\n\nNon-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\n\nNumber needed: 88 patients enrolled\n\nTotal duration of the study: 54 months\n\nDuration of participation for each patient: 24 months\n\nDuration of inclusion: 30 months\n\nMethods:\n\nProspective open multicenter study cognitive. 4 visits are planned as part of this research with some specificity for the different centers.\n\nVisit 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.\n\nVisit 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.\n\nExaminations required specifically for research: duodenal biopsies, additional laboratory tests, biopsies of adipose tissue and pregnancy test (dipstick) for all premenopausal women (contraceptives or not).\n\nPrimary assessment criteria:\n\nThe 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.\n\nsecondary 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 .\n\nThe haematological will assess the presence of anemia (hemoglobin less than 12g/dl) its micro or macrocytic hemolytic and / or regenerative"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* morbid obese women selected for bariatric surgery\n\nExclusion Criteria:\n\n* non obese patients, less than 18 years old, haematological disease with need of blood transfusions'}, 'identificationModule': {'nctId': 'NCT01483768', 'acronym': 'FORBES', 'briefTitle': 'Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Impact of Bariatric Surgery by Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients', 'orgStudyIdInfo': {'id': 'AOR 10083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A:', 'description': 'Sleeve gastrectomy for morbid obesity', 'interventionNames': ['Procedure: Sleeve gastrectomy for morbid obesity']}], 'interventions': [{'name': 'Sleeve gastrectomy for morbid obesity', 'type': 'PROCEDURE', 'otherNames': ['Longitudinal gastrectomy'], 'description': '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.', 'armGroupLabels': ['Arm A:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92701', 'city': 'Colombes', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Simon MSIKA, MD, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}