Type 1 DiabetesBIOMIS-DiabNCT04698122
Establishment of the Human Intestinal and Salivary Microbiota Biobank- Diabetes
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Biological sample collection, Questionnaire and Medical examination
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2021to 2 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 47Show fewer
- 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
- Hypertension
- eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Suspicion, clinical diagnosis or previous history of cancer (<5 years)
- Autoimmune disorders or history of chronic and systemic autoimmune disorders
- Neurodegenerative disorders
- Pregnancy and breastfeeding
- Healthcare workers
- Operators work with animals
- Psychiatric conditions that reduce protocol compliance.
- TYPE 1/TYPE 2 DIABETES
- 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 emergence 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) occurred in the last 3 years
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Suspicion, clinical diagnosis or previous history of cancer (<5 years)
- Autoimmune disorders or history of chronic and systemic autoimmune disorders
- Neurodegenerative disorders
- Pregnancy and breastfeeding
- Psychiatric conditions that reduce protocol compliance.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli Studi di Perugia - Dipartimento di Medicina, S.C. Endocrinologia e Malattie del Metabolismo-Azienda Ospedaliera di Perugia
Perugia
About this study
Official title: Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
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.
Read the detailed description
The primary aim of this monocentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from diabetes mellitus 1 and 2, 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 75 subjects at University of Perugia, 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), filling in of the anamnestic questionnaire, 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.
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).
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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Biological sample collection, Questionnaire, Medical examination
- Keywords
- Microbioma biobank, Biological human samples, diabetes, Meta-omics approaches, Microbiota-pathology relationship
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Collection of faeces, urine, saliva, and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
QuestionnaireOther
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examinationOther
Blood pressure measurement, abdominal and thoracic physical examination
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Patients with type 1 diabetes Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination | |
| type 2 diabetes | Patients with type 2 diabetes Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination | |
| Healthy volunteers | Healthy volunteers Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start27 May 2021
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, University Of Perugia, University of Bari Aldo Moro, University of Salento, Istituti Tumori Giovanni Paolo II
- Responsible party
- Sponsor
- Investigators
- Gianpaolo Reboldi, MD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698122
- Sponsor's protocol ID
- BIOMIS-Diab
- Acronym
- BIOMIS-Diab
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31760385Bordalo 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.
PubMed 26499995Munoz-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.
PubMed 27633134Tilg 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.
PubMed 24833634
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
- ClinicalTrials.gov ID
- NCT04698122
- Acronym / sponsor ID
- BIOMIS-Diab / BIOMIS-Diab
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Microbioma biobank, Biological human samples, diabetes, Meta-omics approaches, Microbiota-pathology relationship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, University Of Perugia, University of Bari Aldo Moro, University of Salento, Istituti Tumori Giovanni Paolo II
- Study start
- 27 May 2021 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this monocentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from diabetes mellitus 1 and 2, 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 75 subjects at University of Perugia, 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), filling in of the anamnestic questionnaire, 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.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationPatients with type 1 diabetes |
| type 2 diabetes | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationPatients with type 2 diabetes |
| Healthy volunteers | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationHealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- HEALTHY VOLUNTEERS
- healthy subjects aged between 18 and 60 years
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
Key exclusion criteria (47 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionCollection of faeces, urine, saliva, and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening | Other | Healthy volunteers, type 1 diabetes, type 2 diabetes |
| QuestionnaireAnamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire | Other | Healthy volunteers, type 1 diabetes, type 2 diabetes |
| Medical examinationBlood pressure measurement, abdominal and thoracic physical examination | Other | Healthy volunteers, type 1 diabetes, type 2 diabetes |
Primary outcome
Biological samples collection for establishment of the first National Microbiome Biobank
Time frame: through study completion, an average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 31760385Yu 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.
- Background: PubMed 26499995Bordalo 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.
- Background: PubMed 27633134Munoz-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.
- Background: PubMed 24833634Tilg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianpaolo Reboldi, MD principal investigator
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological samples collection for establishment of the first National Microbiome Biobank (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04698122, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.