ObesityFORBESNCT01483768
Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
A study testing Sleeve gastrectomy for morbid obesity in people with Obesity and Iron Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Obesity, Iron Deficiency
- What is being tested?
- Sleeve gastrectomy for morbid obesity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- morbid obese women selected for bariatric surgery
Who cannot join
- non obese patients, less than 18 years old, haematological disease with need of blood transfusions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Bariatric Surgery by Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
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)
Read the 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
- Conditions
- Obesity, Iron Deficiency
- Being tested
- Sleeve gastrectomy for morbid obesity
- Keywords
- Sleeve gastrectomy, Obesity surgery, Iron deficiency, HEPCIDINE
- Medical subject headings
- Obesity, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy for morbid obesityProcedure or surgery
Also called Longitudinal gastrectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: | Experimental | Sleeve gastrectomy for morbid obesity Receives: Procedure: Sleeve gastrectomy for morbid obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame 1 year (Time point(s) at which outcome measure is assessed):
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study start25 Sep 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon MSIKA, MD, Ph D, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483768
- Sponsor's protocol ID
- AOR 10083
- Acronym
- FORBES
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2011
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Bariatric Surgery by Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT01483768
- Acronym / sponsor ID
- FORBES / AOR 10083
- Conditions
- Obesity, Iron Deficiency
- Keywords
- Sleeve gastrectomy, Obesity surgery, Iron deficiency, HEPCIDINE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Sep 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A: | Experimental | Procedure: Sleeve gastrectomy for morbid obesitySleeve gastrectomy for morbid obesity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- morbid obese women selected for bariatric surgery
Key exclusion criteria (1 listed)
- non obese patients, less than 18 years old, haematological disease with need of blood transfusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomy for morbid obesityAlso: Longitudinal gastrectomySleeve 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. | Procedure or surgery | Arm A: |
Primary outcome
The intestinal absorption of iron
Time frame: Time Frame 1 year (Time point(s) at which outcome measure is assessed):
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon MSIKA, MD, Ph D principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy for morbid obesity in people with Obesity and Iron Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intestinal absorption of iron (time frame: Time Frame 1 year (Time point(s) at which outcome measure is assessed):). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.