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

Phase 4TerminatedNCT03191201

Prof Gérard WAEBER32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Iron-deficiency Iron Toxicity Glucose Metabolism Disorders (Including Diabetes Mellitus)Metabolic Side Effects of Drugs Metabolic Disorder, Glucose

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.

two-step hyperglycaemic clamp investigation

Time frame: at 28 days of the injection of the Investigation Product

Secondary Outcomes

Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days

plasma hs-CRP levels

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days

plasma hs-CRP levels

Time frame: at 28 days of the injection of the Investigation Product

Change from baseline in interleukin-6 (IL-6) levels at 14 days

plasam IL-6 levels

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in interleukin-6 (IL-6) levels at 28 days

plasam IL-6 levels

Time frame: at 28 days of the injection of the Investigation Product

Change from baseline in adiponectin levels at 14 days

adiponectin

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in adiponectin levels at 28 days

adiponectin

Time frame: at 28 days of the injection of the Investigation Product

Change from baseline in interleukin-1beta levels at 14 days

IL-1b

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in interleukin-1beta levels at 28 days

IL-1b

Time frame: at 28 days of the injection of the Investigation Product

Change from baseline in blood pressure levels at 14 days

systolic and diastolic blood pressure

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in blood pressure levels at 28 days

systolic and diastolic blood pressure

Time frame: at 28 days of the injection of the Investigation Product

Change from baseline in the plasma lipid profile level at 14 days

plasma total- and HDL-cholesterol and plasam triglycerides

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in the plasma lipid profile level at 28 days

plasma total- and HDL-cholesterol and plasam triglycerides

Time frame: at 28 days of the injection of the Investigation Product

Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days

Calculated Homeostasis Model Assessment (HOMA-2) index

Time frame: at 14 days of the injection of the Investigation Product

Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days

Calculated Homeostasis Model Assessment (HOMA-2) index

Time frame: at 28 days of the injection of the Investigation Product

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes