insulin resistance, obesity and gastrointestinal bacteria

Conditions: Helicobacter pylori infection
MedDRA version: 18.1Level: PTClassification code 10022489Term: Insulin resistanceSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.1Level: LLTClassification code 10004028Term: Bacterial infection due to helicobacter pylori (H. pylori)System Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2015-000197-35-IT

Lead Sponsor: AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

• proven hyper-insulinismo (using OGTT)
• BMI> 24.9 kg / m2 and <39.9 kg / m2
• Age = 18 years and = 65
• Informed consent 1 [ for the immunoassay on stool]
• Informed consent 2 [for Visit1 enrollment]
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have already performed a therapy for the eradication of Helicobacter pylori, including proton pump inhibitors, preparations of bismuth, prokinetic or antibiotics in the two previous months;
• Patients who make use of drugs including anti-inflammatory and / or aspirin, glucose and lipid-lowering agents; alcohol addiction; previous gastric surgery; decompensated congestive heart failure; liver cirrhosis; chronic renal failure; diagnosis of cancer; pregnancy; systemic or local infections
• Women of childbearing potential not using contraception and breastfeeding women;
• Known or suspected hypersensitivity to the drug or drug class in the studio;
• Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study;
• Use of experimental drugs in the last three months prior to study entry.