Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Side Effects of Drugs, Metabolic Disorder, Glucose, Safety Issues
Conditions
Keywords
Metabolomics, Transcriptomics, Ironomics
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.
Interventions
DRUGFerric Carboxymaltose
Ferric Carboxymaltose 1000 mg iron element will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution.
250 mL of a commercially available sterile 0.9% sodium chloride solution.
Sponsors
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
University of Lausanne
Prof Gérard WAEBER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation. | at 28 days of the injection of the Investigation Product | two-step hyperglycaemic clamp investigation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in adiponectin levels at 14 days | at 14 days of the injection of the Investigation Product | adiponectin |
| Change from baseline in adiponectin levels at 28 days | at 28 days of the injection of the Investigation Product | adiponectin |
| Change from baseline in interleukin-1beta levels at 14 days | at 14 days of the injection of the Investigation Product | IL-1b |
| Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days | at 14 days of the injection of the Investigation Product | plasma hs-CRP levels |
| Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days | at 28 days of the injection of the Investigation Product | plasma hs-CRP levels |
| Change from baseline in interleukin-6 (IL-6) levels at 14 days | at 14 days of the injection of the Investigation Product | plasam IL-6 levels |
| Change from baseline in interleukin-6 (IL-6) levels at 28 days | at 28 days of the injection of the Investigation Product | plasam IL-6 levels |
| Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days | at 14 days of the injection of the Investigation Product | Calculated Homeostasis Model Assessment (HOMA-2) index |
| Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days | at 28 days of the injection of the Investigation Product | Calculated Homeostasis Model Assessment (HOMA-2) index |
| Change from baseline in interleukin-1beta levels at 28 days | at 28 days of the injection of the Investigation Product | IL-1b |
| Change from baseline in blood pressure levels at 14 days | at 14 days of the injection of the Investigation Product | systolic and diastolic blood pressure |
| Change from baseline in blood pressure levels at 28 days | at 28 days of the injection of the Investigation Product | systolic and diastolic blood pressure |
| Change from baseline in the plasma lipid profile level at 14 days | at 14 days of the injection of the Investigation Product | plasma total- and HDL-cholesterol and plasam triglycerides |
| Change from baseline in the plasma lipid profile level at 28 days | at 28 days of the injection of the Investigation Product | plasma total- and HDL-cholesterol and plasam triglycerides |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the plasma metabolomic profiling as assessed by metabolomics | at 14 and 28 days of the injection of the Investigation Product | Metabolomics |
| Change from baseline in circulating miRNAs | at 14 and 28 days of the injection of the Investigation Product | selected miRNA as measured by qPCR |
Countries
Switzerland
Outcome results
None listed