Establishment of the Human Intestinal and Salivary Microbiota Biobank- Diabetes

NCT04698122 | Completed

• 1 other identifier: BIOMIS-Diab
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from type 1 diabetes mellitus, subjects suffering from type 2 diabetes mellitus and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological). The study will allow to:

• Provide biological samples (faeces, saliva, blood, urine) from healthy volunteers and patients suffering with diabetes mellitus 1 and 2 to the first Italian microbiota biobank;
• Study microorganisms using different in vitro and in vivo techniques;
• Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01\_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Microbioma biobank; Biological human samples; diabetes; Meta-omics approaches; Microbiota-pathology relationship

Outcome Measures

Primary Outcomes (1)

• Biological samples collection for establishment of the first National Microbiome Biobank

  Recruitment of 75 subjects (type 1 diabetes, type 2 diabetes patients and healthy volunteers) to collect biological samples for establishment of the first National Microbiome Biobank

  through study completion, an average of 1 year

Study Arms (3)

type 1 diabetes

Patients with type 1 diabetes

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

type 2 diabetes

Patients with type 2 diabetes

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Healthy volunteers

Healthy volunteers

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Interventions

Biological sample collection OTHER

Collection of faeces, urine, saliva, and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening

Healthy volunteers; type 1 diabetes; type 2 diabetes

Questionnaire OTHER

Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire

Healthy volunteers; type 1 diabetes; type 2 diabetes

Medical examination OTHER

Blood pressure measurement, abdominal and thoracic physical examination

Healthy volunteers; type 1 diabetes; type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 and 2 diabetes attending the clinical centres involved in the study. Healthy volunteers will be recruited by invitation. Enrolled subjects must not have any family relationship and hierarchical subordination with the hospitals in which biological samples will be collected.

You may qualify if:

• HEALTHY VOLUNTEERS
• healthy subjects aged between 18 and 60 years
• BMI between 18.5-30
• omnivorous diet
• signature of the informed consent
• TYPE 1/TYPE 2 DIABETES
• subjects with type 1 diabetes aged between 18 and 50 years, type 2 diabetes aged between 18 and 65 years
• creatinine clearance \> 60 mL / min
• Normoalbuminurics (ACR \<30 mg / g)
• Absence of diabetic retinopathy
• DM duration \<5 years
• Not being treated with metformin
• BMI between 18.5-30
• omnivorous diet
• signature of the informed consent

You may not qualify if:

• HEALTHY VOLUNTEERS
• Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
• Chronic liver disease
• History of Clostridium difficile infections
• Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
• Chronic therapy with proton pump inhibitors
• Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
• Previous history of organ / tissue transplantation
• Recent onset of diarrhea
• Chronic diarrhea
• Chronic constipation
• Previous gastrointestinal surgery (eg gastric bypass)
• Recurring urinary tract infections (3 cases per year)
• Previous major acute cardiovascular diseases (myocardial infarction, stroke)
• Type 2 diabetes mellitus

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies: collaborator
• University Of Perugia: collaborator
• University of Bari Aldo Moro: collaborator
• University of Salento: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator

Study Sites (1)

Università degli Studi di Perugia - Dipartimento di Medicina, S.C. Endocrinologia e Malattie del Metabolismo-Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Related Publications (4)

• Yu F, Han W, Zhan G, Li S, Jiang X, Wang L, Xiang S, Zhu B, Yang L, Luo A, Hua F, Yang C. Abnormal gut microbiota composition contributes to the development of type 2 diabetes mellitus in db/db mice. Aging (Albany NY). 2019 Nov 23;11(22):10454-10467. doi: 10.18632/aging.102469. Epub 2019 Nov 23.

  PMID: 31760385 BACKGROUND

• Bordalo Tonucci L, Dos Santos KM, De Luces Fortes Ferreira CL, Ribeiro SM, De Oliveira LL, Martino HS. Gut microbiota and probiotics: Focus on diabetes mellitus. Crit Rev Food Sci Nutr. 2017 Jul 24;57(11):2296-2309. doi: 10.1080/10408398.2014.934438.

  PMID: 26499995 BACKGROUND

• Munoz-Garach A, Diaz-Perdigones C, Tinahones FJ. Gut microbiota and type 2 diabetes mellitus. Endocrinol Nutr. 2016 Dec;63(10):560-568. doi: 10.1016/j.endonu.2016.07.008. Epub 2016 Sep 12. English, Spanish.

  PMID: 27633134 BACKGROUND

• Tilg H, Moschen AR. Microbiota and diabetes: an evolving relationship. Gut. 2014 Sep;63(9):1513-21. doi: 10.1136/gutjnl-2014-306928. Epub 2014 May 15.

  PMID: 24833634 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, blood, serum, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Surveys and Questionnaires; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gianpaolo Reboldi, MD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 6, 2021
• Study Start: May 27, 2021
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)