Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Metabolically Healthy Obesity
  • Morbid Obesity
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

The primary aim of this multicentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from selected disease (morbid obesity, metabolically healthy obesity), and healthy volunteers. The secondary aim is ...

The primary aim of this multicentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from selected disease (morbid obesity, metabolically healthy obesity), and healthy volunteers. The secondary aim is the characterization of microorganisms of the biobank and study of the microbiota-pathology relationship using meta-omics, in vitro and in vivo approaches. The study plans to enrol 60 subjects at Policlinico of Bari, according to the inclusion/exclusion criteria. The study participation is voluntary, and the subjects have the right to withdraw from the study at any time and for any reason. During the study, 3 visits are planned: Visit 0 (V0), including description of the objectives and procedures study, signature written informed consent, inclusion/exclusion criteria evaluation, medical examination (blood pressure measurement, abdominal and thoracic physical examination), body composition through bioimpedance analysis and metabolic, cardiovascular and respiratory variables; OGTT 75gr for blood glucose and insulin at times 0, 30, 60, 90 and 120', and a nocturnal oximetry and subsequently, if necessary, overnight polysomnography for the diagnosis of obstructive sleep, filling in of the anamnestic questionnaire, delivery of the coproculture kit, delivery of kits for the collection of fecal, salivary and urinary material to be reported at Visit 1 and delivery of a 3-day food diary, to be completed autonomously in the days preceding the Visit 1. Visit 1 (V1) - at least 4 days after V0, including delivery of the of the collected biological material (feces, saliva, urine), and of a 3-day food diary, filling in of the new signs and symptoms anamnestic questionnaire and blood sampling by medical staff. Telephone evaluation: administration of a "Food Frequency Questionnaire" to assess the subjects' alimentary habits. Standard Operative Procedures (SOP) for samples storing, transport and processing will be adopted to ensure samples stability and grant results validity and quality. Following collections, samples will be processed in different aliquots that will be used for: routine screening; storage in the first Italian human microbiote biobank (I.R.C.C.S. - Istituto Tumori "Giovanni Paolo II", Bari); evaluation of the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile; Evaluation of the transcriptomic profile of PBMCs of healthy subjects and subjects affected by selected pathologies and evaluation of the serum proteomic profile Furthermore, molecular characterization of pathogenic microorganisms and pathogenic biotypes (pathovars) of commensal species of subjects with selected pathologies will be conducted. Part of the biological material will be used for animal studies on the physiopathological role of the human intestinal microbiota transplanted into mouse models of pathology and Germ-free mouse models (specific animal study protocol developed). Also, in vitro studies on mucosal models to evaluate the interaction between the microbiota and the intestinal mucosa will be conducted. The study foresees no more than minimal risk associated with blood sampling procedures. All the necessary measures to avoid any risks / inconveniences resulting from participation of the subject under study will be taken. The study is compliant with Good Clinical Practice. Study protocol and all related documents have been approved by approved by the Independent Ethics Committees (IEC) of the involved clinical sites. To ensure the protection and confidentiality of the participants' data, all study activities will be carried out in accordance with the European General Data Protection Regulation, Regulation (EU) 2016/679, which repeals Directive 95/46/EC.

Tracking Information

NCT #
NCT04698135
Collaborators
  • University of Bari Aldo Moro
  • University of Salento
  • Istituti Tumori Giovanni Paolo II
  • Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
Investigators
Principal Investigator: Francesco Giorgino, MD Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari