insulin resistance, obesity and gastrointestinal bacteria

insulin resistance, obesity and gastrointestinal bacteria - HR-HP-14-01

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000197-35-IT

Enrollment

100

Registered

2016-03-11

Start date

2015-06-09

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection MedDRA version: 18.1 Level: PT Classification code 10022489 Term: Insulin resistance System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 18.1 Level: LLT Classification code 10004028 Term: Bacterial infection due to helicobacter pylori (H. pylori) System Organ Class: 100000004862

Interventions

Trade Name: PANTORC - 14 COMPRESSE GASTRORESISTENTI DA 40 MG IN BLISTER Pharmaceutical Form: Tablet INN or Proposed INN: PANTOPRAZOLO SODICO SESQUIDRATO CAS Number: 164579-32-2 Current Sponsor code: n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • proven hyper-insulinismo (using OGTT) • BMI> 24.9 kg / m2 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the effects of eradication of Helicobacter pylori in patients with proven hyper-insulinismo, using drug treatment as a standard triple therapy (40 mg pantoprazole, clarithromycin 500 mg and amoxicillin 1 g twice daily for 10 days) on insulin resistance, with an interventional study with medicine, randomized, double-blind, placebo-controlled study.;Secondary Objective: Secondary objectives of the study are: 1) compare the role of eradication on the endpoint to a possible primary role of antibiotics; 2) evaluate, with methods of proteomics, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance; 3) assessing, metabolomics methods, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance 4) assess the possible variation of the intestinal flora before and after drug treatment using genomic analysis of bacterial fecal sample; 5) whether the set of metabolic and inflammatory patients with proven hyper-insulinismo but negative to infection by Helicobacter pylori infection differs from the positive group and the group turned negative to infection as a result of eradication treatment. ;Primary end point(s): evaluate, with a prospective, double-blind,randomized, placebo-controlled study the effects of Helicobacter Pylori eradication on insulin resistance as well as the serum/plasma related markers.;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the effects of eradication of Helicobacter pylori in patients with proven hyper-insulinismo, using drug treatment as a standard triple therapy (40 mg pantoprazole, clarithromycin 500 mg and amoxicillin 1 g twice daily for 10 days) on insulin resistance, with an interventional study with medicine, randomized, double-blind, placebo-controlled study.;Secondary Objective: Secondary objectives of the study are: 1) compare the role of eradication on the endpoint to a possible primary role of antibiotics; 2) evaluate, with methods of proteomics, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance; 3) assessing, metabolomics methods, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance 4) assess the possible variation of the intestinal flora before and after drug treatment using genomic analysis of bacterial fecal sample; 5) whether the set of metabolic and inflammatory patients with proven hyper-insulinismo but negative to infection by Helicobacter pylori infection differs from the positive group and the group turned negative to infection as a result of eradication treatment. ;Primary end point(s): evaluate, with a prospective, double-blind,randomized, placebo-controlled study the effects of Helicobacter Pylori eradication on insulin resistance as well as the serum/plasma related markers.;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): compare the role of eradication on the endpoint to a possible primary role of antibiotics; 2) evaluate, with methods of proteomics, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance; 3) assessing, metabolomics methods, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance 4) assess the possible variation of the intestinal flora before and after drug treatment using genomic analysis of bacterial fecal sample; 5) whether the set of metabolic and inflammatory patients with proven hyper-insulinismo but negative to infection by Helicobacter pylori infection differs from the positive group and the group turned negative to infection as a result of eradication treatment.;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Secondary end point(s): compare the role of eradication on the endpoint to a possible primary role of antibiotics; 2) evaluate, with methods of proteomics, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance; 3) assessing, metabolomics methods, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance 4) assess the possible variation of the intestinal flora before and after drug treatment using genomic analysis of bacterial fecal sample; 5) whether the set of metabolic and inflammatory patients with proven hyper-insulinismo but negative to infection by Helicobacter pylori infection differs from the positive group and the group turned negative to infection as a result of eradication treatment.;Timepoint(s) of evaluation of this end point: 30 days

—

Countries

Italy

Contacts

Public ContactU.O. Medicina Interna (Direttore St

AOU di Bologna, Policlinico S.Orsola-Malpighi

federico.perna@unibo.it051-6364134

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026