Status:
COMPLETED
Establishment of the Human Intestinal and Salivary Microbiota Biobank- Diabetes
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
University Of Perugia
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
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 diabet...
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 mel...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04698122
Start Date
May 27 2021
End Date
February 2 2022
Last Update
February 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Università degli Studi di Perugia - Dipartimento di Medicina, S.C. Endocrinologia e Malattie del Metabolismo-Azienda Ospedaliera di Perugia
Perugia, Italy