ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018
Intravenous Ferric Carboxymaltose in Patients with Type 2 Diabetes Mellitus and Iron Deficiency: CLEVER Trial Study Design and Protocol.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01513369 (Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency), which is not on this map. Cited by 8 papers.
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Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency
Who cites it
8 citing papers in PubMed, 16 citations in OpenAlex.
- Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial.Cardiovascular diabetology · 2023Trial
- Impact of obesity on iron metabolism and the effect of intravenous iron supplementation in obese patients with absolute iron deficiency.Scientific reports · 2025Article
- The Prevalence and Characteristics of Anemia in Romanian Patients with Type 2 Diabetes: A Cross-Sectional Study.Journal of clinical medicine · 2024Article
- Potential Mediating Role of Iron Biomarkers in the Association of Sex With Glucose, Insulin, and Type 2 Diabetes.Journal of the Endocrine Society · 2024Article
- Article
- The Association Between Cost-Related Non-Adherence Behaviors and Diabetes Outcomes.Journal of the American Board of Family Medicine : JABFM · 2023Article
- Article
- Iron deficiency as energetic insult to skeletal muscle in chronic diseases.Journal of cachexia, sarcopenia and muscle · 2018Review
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHbA1c is the gold standard for glycemic control in pre-diabetes and diabetes. However, its validity has been questioned, especially in the presence of imbalanced iron homeostasis. The CLEVER trial aims to evaluate the relationship between iron deficiency and HbA1c (a biomarker for the diagnosis and therapeutic monitoring of type 2 diabetes) in a randomized, placebo-controlled, multicenter clinical trial.
methodsThe CLEVER (intravenous ferric CarboxymaLtosE for improVement of mEtabolic parameters in type 2 diabetes patients with iRon deficiency) trial is a randomized, single-blind, proof-of-concept study with two treatment arms. 140 men and women diagnosed with type 2 diabetes and iron deficiency will receive either placebo or ferric carboxymaltose (500 or 1000 mg) as intravenous infusions. The primary outcome measure is the change in HbA1c level between baseline and after 12 weeks of treatment. Secondary endpoints include change of iron status and metabolic markers as well as treatment safety and tolerability. Furthermore, the potential clinical improvement in quality of life and the reliability of HbA1c measurement in patients with type 2 diabetes and iron deficiency will be investigated.
resultsBoth excessive iron and iron deficiency are associated with metabolic disorders; excessive iron is a risk factor for the development of diabetes, whereas iron deficiency is associated with obesity and insulin resistance. It has been suggested that iron increases insulin secretion in pancreatic beta-cells. CLEVER is the first study to investigate the hypothesis that intravenous substitution with ferric carboxymaltose reduces HbA1c levels in patients with type 2 diabetes and iron deficiency, thereby improving metabolic status and quality of life. CLINICAL
trial registrationClinicalTrials.gov (NCT01513369).
fundingGWT-TUD GmbH acts as sponsor of the clinical trial. Financial support is provided by Vifor Pharma.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.