title: Randomized, double-blind, placebo-controlled trial to evaluate the effect of Helicobacter pylori eradication on glucose homeostasis in type 2 diabetic patients.
abstract: Literature data suggest an association between Helicobacter pylori infection and glucose homeostasis. However, a causative link between them has not been demonstrated yet. The aim of this study is to investigate the effect of H. pylori eradication on glucose homeostasis in patients with type 2 diabetes.
  
  
  
  A randomized, double-blind, placebo-controlled trial was conducted to investigate the effect of H. pylori eradication on glucose homeostasis in 154 patients with type 2 diabetes and who tested positive for H. pylori infection (mean age (SD), 63.1 (8.1) years). Subjects were assigned to H. pylori eradication treatment or placebo. Metabolic and inflammatory parameters were measured in all subjects at baseline and 4 weeks after the treatment. H. pylori eradication led to an improvement in glucose homeostasis, measured by HOMA-IR (p < 0.001) and KITT (0 = 0.041), due to the decrease in fasting insulin levels (p = 0.004). The results also showed that lower levels of inflammatory parameters were present after eradication.
  
  
  
  To our knowledge this is the first randomized, double blind, controlled study where the effect of H. pylori eradication on glucose homeostasis in subjects with type 2 diabetes has been investigated. Our findings demonstrate that H. pylori eradication improves glucose homeostasis in patients with type 2 diabetes through a decrease in pro-inflammatory factors.
  
  
  
  ACTRN12609000255280 (https://www.anzctr.org.au/).
authors.affiliation: Scientific Direction, Italian National Research Center on Aging (INRCA), Ancona, Italy. Electronic address: a.bonfigli@inrca.it.
authors.forename: A R
authors.initials: AR
authors.lastname: Bonfigli
authors.affiliation: Metabolic Diseases and Diabetology Unit, Italian National Research Center on Aging (INRCA), Ancona, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Boemi
authors.affiliation: Department of Primary Care, ASUR Marche, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Festa
authors.affiliation: Department of Gastroenterology, Polytechnic University of Marche, Ancona, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Bonazzi
authors.affiliation: Metabolic Diseases and Diabetology Unit, Italian National Research Center on Aging (INRCA), Ancona, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Brandoni
authors.affiliation: Statistic and Biometry Centre, Italian National Research Center on Aging (INRCA), Ancona, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Spazzafumo
authors.affiliation: Centre of Clinical Pathology and Innovative Therapy, Italian National Research Center on Aging (INRCA), Ancona, Italy; Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Ancona, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Olivieri
authors.affiliation: Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Ceriello
authors.affiliation: Department of Cardiovascular and Metabolic Diseases, IRCCS Gruppo Multimedica Sesto San Giovanni, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Genovese
authors.affiliation: Experimental Models in Clinical Pathology, Italian National Research Center on Aging (INRCA), Ancona, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Testa
mesh_terms: D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism*; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000175:diagnosis / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D016481:Helicobacter Infections / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000472:pathogenicity; D006706:Homeostasis; D054884:Host-Pathogen Interactions; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D007558:Italy; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D015415:Biomarkers; D001786:Blood Glucose; D018836:Inflammation Mediators; D007328:Insulin; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole
keywords: Diabetes mellitus type 2; Helicobacter pylori; Inflammation; Insulin resistance; Randomized clinical trial