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Trial record 60 of 380 for:    FERRIC CATION

A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis. (DIAFER)

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ClinicalTrials.gov Identifier: NCT03191201
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
University of Lausanne
Information provided by (Responsible Party):
Prof Gérard WAEBER, University of Lausanne

Brief Summary:
In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome and parameters related to glucose homeostasis, parameters related to metabolic syndrome and inflammation will be measured before and after the intervention.

Condition or disease Intervention/treatment Phase
Iron-deficiency Iron Toxicity Glucose Metabolism Disorders (Including Diabetes Mellitus) Metabolic Side Effects of Drugs Metabolic Disorder, Glucose Safety Issues Drug: Ferric Carboxymaltose Drug: 0.9% sodium chloride solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Double blind randomised placebo-controlled, parallel group comparative inferiority study with open-label extension divided in two parts:

  • A first randomised and double-blind part in which FCM or placebo will be administered at baseline and post-baseline parameters assessed.
  • A second non-randomised, non-blinded open-label extension part starting at the end of part 1, in which participants randomised to the placebo group will receive a FCM injection and post-baseline parameters assessed.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

To ensure that patients are unaware of the study drug they are receiving, the infusion pouch will be prepared in a separate room by members of the pharmacy unit and opaque bags will cover the infusion kits and infusions will be done via dark coloured infusion sets. Finally, a curtain will be used to shield the injection site from the patient's view.

To ensure that Outcomes Assessors are unaware of the study drug the patient is receiving, a seperate team of care providers will supervise the infusion of the investigation product and collect and/or manage adverse events (AEs) and serious adverse events (SAEs). The Outcome Assessor will not have access to participant related data during the randomised part of the study.

Primary Purpose: Other
Official Title: A Double Blind Randomised Placebo-controlled Trial to Assess the Effect of a Single Administration of Ferric Carboxymaltose of 1000 mg Iron on Glucose Homeostasis, in Iron-deficient Non-anaemic Women of Childbearing Age.
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: Ferric carboxymaltose arm
Ferric carboxymaltose (FCM), 1000 mg iron element will be administered once by drip infusion (Intravenous route). FCM will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution prior to administration. Infusion time will be 15 minutes.
Drug: Ferric Carboxymaltose
Ferric Carboxymaltose 1000 mg iron element will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution.

Placebo Comparator: Placebo arm

A commercially available sterile, 250 mL, 0.9% sodium chloride solution will be administered by drip infusion (Intravenous route). Infusion time will be 15 minutes.

At the end of the randomised part of the study, participants initially randomised to the placebo group will be included in a non-blinded open-label extension part and receive a FCM 1000 mg injection.

Drug: 0.9% sodium chloride solution
250 mL of a commercially available sterile 0.9% sodium chloride solution.




Primary Outcome Measures :
  1. Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation. [ Time Frame: at 28 days of the injection of the Investigation Product ]
    two-step hyperglycaemic clamp investigation


Secondary Outcome Measures :
  1. Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    plasma hs-CRP levels

  2. Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    plasma hs-CRP levels

  3. Change from baseline in interleukin-6 (IL-6) levels at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    plasam IL-6 levels

  4. Change from baseline in interleukin-6 (IL-6) levels at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    plasam IL-6 levels

  5. Change from baseline in adiponectin levels at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    adiponectin

  6. Change from baseline in adiponectin levels at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    adiponectin

  7. Change from baseline in interleukin-1beta levels at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    IL-1b

  8. Change from baseline in interleukin-1beta levels at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    IL-1b

  9. Change from baseline in blood pressure levels at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    systolic and diastolic blood pressure

  10. Change from baseline in blood pressure levels at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    systolic and diastolic blood pressure

  11. Change from baseline in the plasma lipid profile level at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    plasma total- and HDL-cholesterol and plasam triglycerides

  12. Change from baseline in the plasma lipid profile level at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    plasma total- and HDL-cholesterol and plasam triglycerides

  13. Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days [ Time Frame: at 14 days of the injection of the Investigation Product ]
    Calculated Homeostasis Model Assessment (HOMA-2) index

  14. Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days [ Time Frame: at 28 days of the injection of the Investigation Product ]
    Calculated Homeostasis Model Assessment (HOMA-2) index


Other Outcome Measures:
  1. Change from baseline in the plasma metabolomic profiling as assessed by metabolomics [ Time Frame: at 14 and 28 days of the injection of the Investigation Product ]
    Metabolomics

  2. Change from baseline in circulating miRNAs [ Time Frame: at 14 and 28 days of the injection of the Investigation Product ]
    selected miRNA as measured by qPCR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women.
  • Negative pregnancy test.
  • Adequate contraception during the study period and for 1 month following study completion.
  • Overt or relative iron deficiency at screening defined as follows:

Serum ferritin <50 ng/mL AND transferrin saturation <20%, OR Serum ferritin <30 ng/mL.

- Serum C-reactive protein: <5 mg/L if not on oral contraception, OR <20 mg/L if use of oral contraception

  • Intolerance to oral iron formulations, or lack of efficacy of oral iron formulations.
  • Minimum total score of 5 on the Visual analogic scale of fatigue.
  • Normal levels of vitamin B12 and folic acid at screening.
  • Availability and willingness to complete all study visits and procedures per protocol.
  • Ability to sign an informed consent.

Exclusion Criteria:

  • Age <18 years.
  • Menopause (defined as an amenorrhea of at least 12 months).
  • Irregularly menstruating women (menstrual cycle outside a range of 24-38 days in duration) or experiencing overt metrorrhagia (simple spotting not being an exclusion criteria).
  • Body mass index <18.5 kg/m2 or >30 kg/m2.
  • Diabetes, defined as subjects with HbA1c ≥ 6.5 % and/or with fasting blood glucose levels ≥ 7 mmol/l and/or with a history of diabetes and/or by the use of anti-diabetic drugs.
  • Hb level <117 g/L or known haemoglobinopathy or haemochromatosis.
  • Blood transfusion within the last 12 weeks.
  • Intake of iron preparations 4 weeks prior to screening.
  • Known hypersensitivity to FCM or to any other iron preparation.
  • Suspicion of major depressive disorder based on Patient Health Questionnaire.
  • Known chronic inflammatory disease, including human immunodeficiency virus, hepatitis B or hepatitis C virus infection.
  • Active malignancy.
  • Decreased renal function (estimated glomerular filtration rate using the CKD-EPI equation<60 ml/min/1.73m2).
  • Liver dysfunction (aspartate aminotransferase and alanine aminotransferase > 3-fold upper limit).
  • Angina (Class IV).
  • Asthma.
  • Documented sleep apnoea.
  • Important recent weight loss (>10% within the past month).
  • Thyroid dysfunction (thyroid stimulating hormone >4 µU/mL).
  • Reported weekly alcohol consumption > 14 standard drinks.
  • Drug abuse (any drug consumption reported in the past 12 months).

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): NCT03191201


Contacts
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Contact: Gérard Waeber, MD 21 314 09 63 ext +41 Gerard.Waeber@chuv.ch
Contact: Evrim Jaccard, MD-PhD 21 556 48 79 ext +41 Evrim.Jaccard@chuv.ch

Locations
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Switzerland
Policlinique Médicale Universitaire Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Bernard Favrat, MD    21 314 49 06 ext +41    Bernard.Favrat@chuv.ch   
Contact: Cornuz Jacques, MD    21 314 05 06 ext +41    Jacques.Cornuz@chuv.ch   
Sub-Investigator: Luc Tappy, MD         
Sub-Investigator: Favrat Bernard, MD         
Sub-Investigator: Evrim Jaccard, MD-PhD         
Principal Investigator: Gérard Waeber, MD         
Sub-Investigator: Pedro-Manuel Marques-Vidal, MD-PhD         
Sub-Investigator: Marc Froissart, MD-PhD         
Sub-Investigator: Cédric Gubelmann, Med         
Sub-Investigator: Laila Baratali, Med         
Sub-Investigator: Kévin Seyssel, PhD         
Sponsors and Collaborators
Prof Gérard WAEBER
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
University of Lausanne
Investigators
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Study Director: Gérard Waeber, MD Centre Hospitalier Universitaire Vaudois (CHUV)

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Responsible Party: Prof Gérard WAEBER, Head of the Department of Medicine, University of Lausanne
ClinicalTrials.gov Identifier: NCT03191201     History of Changes
Other Study ID Numbers: 2016-01449
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof Gérard WAEBER, University of Lausanne:
Metabolomics, Transcriptomics, Ironomics
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Disease
Drug-Related Side Effects and Adverse Reactions
Metabolic Side Effects of Drugs and Substances
Pathologic Processes
Chemically-Induced Disorders
Ferric Compounds
Pharmaceutical Solutions
Hematinics