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Trial record 11 of 12 for:    Endocrine Disruptors

Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus (ISOLED)

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ClinicalTrials.gov Identifier: NCT03421184
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed as a confounding risk factor.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus Rheumatoid Arthritis Autoimmune Thrombocytopenia Other: blood sample Other: urine sample Other: food questionnaire Other: hair Not Applicable

Detailed Description:

SLE is a disease occurring in 90% of the cases in pre-menopausal women. The causing factors are largely unknown even though genetic and environmental factors have already been identified. Estrogens, on one side, have been shown to negatively influence the incidence and severity of the disease while testosterone and progesterone on the other side are thought to be protective. Endocrine disruptors can potentially influence the occurrence and severity of the disease. Among these disruptors, soy isoflavones which are ubiquitous in modern processed food are known to be estrogenic and anti-androgenic. Their depleting effect on luteinizing hormone (LH) secretion can also lead to progesterone plasma level impairments. For these reasons, estrogenic isoflavones, appear as potential environmental risk factors for SLE and its flares. Although some data exist in transgenic rodent, there is actually no clinical data in young women.

The study is an observational, monocentric, preliminary study aiming at determining if estrogenic isoflavones can be risk factors for SLE. No treatment is planned. The intervention will be the collection of extra blood and urine samples on SLE subjects and on autoimmune and healthy counterparts.

Consumers are unintentionally exposed to estrogenic isoflavones through their diet. A dietary habit enquiry and a 48h dietary recall (based on pharmacokinetics of soy-isoflavones) will be proposed to the included subjects. Urine and blood samples collected during a clinical visit performed 7 days after the onset of previous menses will be analyzed for soy isoflavones, metabolites and for enterolactone both free and conjugated. Free estradiol will be assayed as a potential confounding risk factor.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Patient with Systemic Lupus Erythematosus
30 women with SLE
Other: blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Other: urine sample
10 ml

Other: food questionnaire
dietary habit enquiry and a 48h dietary

Other: hair
lock of hair

Active Comparator: Patients with other autoimmune diseases
20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia
Other: blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Other: urine sample
10 ml

Other: food questionnaire
dietary habit enquiry and a 48h dietary

Other: hair
lock of hair

Active Comparator: Healthy control
30 healthy control women
Other: blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Other: urine sample
10 ml

Other: food questionnaire
dietary habit enquiry and a 48h dietary

Other: hair
lock of hair




Primary Outcome Measures :
  1. Quantification of different isoflavones and enterolactone [ Time Frame: At baseline (day 0) ]
    in the blood and urine of patients and healthy controls


Secondary Outcome Measures :
  1. Quantification of free estradiol concentrations [ Time Frame: At baseline (day 0) ]
    in the blood and urine of patients and healthy controls



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group : Systemic Lupus Erythematosus :

    • Premenopausal women over 18
    • with acute LEAD flare
    • having given informed consent
    • and being covered by social insurance.
  • Group : Autoimmune diseases :

    • Premenopausal women of matching age with other autoimmune disease,
    • having given informed consent
    • and being covered by social insurance.
  • Healthy controls :

    • Premenopausal women over 18,
    • having given informed consent,
    • and being covered by social insurance.

Exclusion Criteria:

  • Group Systemic Lupus Erythematosus and group autoimmune diseases

    • Human Immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis C virus (HBV) sero-positivity;
    • pregnant or lactating women;
    • menopausal women;
    • patient in remission of quiescent phase of her pathology;
  • Healthy controls :

    • HIV, HCV or HBV sero-positivity;
    • pregnant or lactating women;
    • menopausal women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421184


Contacts
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Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.viallard@chu-bordeaux.fr
Contact: Isabelle RAYMOND, Pharm

Locations
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France
CHU de Bordeaux - service de médecine interne Recruiting
Pessac, France
Contact: Jean-François VIALLARD, Prof    05.57.65.64.83 ext +33    jean-françois.viallard@chu-bordeaux.fr   
Contact: Isabelle RAYMOND, Pharm         
Principal Investigator: Jean-François VIALLARD, Prof         
Sub-Investigator: Estibaliz LAZARO, Prof         
Sub-Investigator: Jean-Luc PELLEGRIN, Prof         
Sub-Investigator: Carine GREIB, MD         
Sub-Investigator: Irene MACHELARD, MD         
Sub-Investigator: Marion MIRABEL, MD         
Sub-Investigator: Etienne RIVIERE, MD         
Sub-Investigator: Thierry SCHAEVERBEKE, Prof         
Sub-Investigator: Christophe RICHEZ, Prof         
Sub-Investigator: Marie-Elise TRUCHETET, MD         
Sub-Investigator: Nicolas POURSAC, MD         
Sub-Investigator: Nadia MEHSEN, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Jean-François VIALLARD, Prof CHU - Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03421184     History of Changes
Other Study ID Numbers: CHUBX 2017/18
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
autoimmune disease
endocrine disruptors
isoflavones
lignans
diet exposure
risk factor

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs