Residual beta cell function and microbiome in type 1 diabetes

Is the gut microbiome associated with residual beta cell function in longstanding type 1 diabetes

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25270

Enrollment

500

Registered

2020-09-24

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

type 1 diabetes

Interventions

none

Eligibility

Inclusion criteria

Inclusion criteria: All individuals with T1D visiting the outpatient clinic of recruiting centres in the greater Amsterdam region >18 years old.

Exclusion criteria

Exclusion criteria: - Active infection at the time of inclusion (not to influence immune-cell function) • Antibiotic or proton-pump inhibitor use last 3 months (not to influence microbiome) • Unwillingness to donate feces, urine and/or blood • Inability to provide informed consent based on cognitive function, language barrier or other reasons • Absence of large bowel (ie colostomy).

Design outcomes

Primary

Measure	Time frame
associations between residual beta cell function (2-hour post-meal urinary C-peptide / creatinine ratio), gut microbiome composition and circulating T-cell immune cell function	—

Secondary

Measure	Time frame
Correlation of above mentioned primary endpoints with: -Frequency of Hypoglycemia • Awareness of hypoglycemia • presence off Diabetic complications • Circulating (T cell) immune cell panel including HLA type • Fecal microbial composition (illumina 16s ribosomal RNA sequencing) • Plasma microbial metabolomics • Sex • Age • Duration of type 1 diabetes • Smoking • Medication use • Diabetic complications • Abdominal complaints Recorded at the study visit • Blood pressure • BMI • Glucose time in range from continuous glucose monitoring device (Free style libre) . • Serum creatinine and calculated eGFR • Lipid profile (total cholesterol, HDL, LDL triglycerids) • urinary Albuminuria/creatinine ratio • HbA1c • CRP	—

Measure

Time frame

Correlation of above mentioned primary endpoints with: -Frequency of Hypoglycemia • Awareness of hypoglycemia • presence off Diabetic complications • Circulating (T cell) immune cell panel including HLA type • Fecal microbial composition (illumina 16s ribosomal RNA sequencing) • Plasma microbial metabolomics • Sex • Age • Duration of type 1 diabetes • Smoking • Medication use • Diabetic complications • Abdominal complaints Recorded at the study visit • Blood pressure • BMI • Glucose time in range from continuous glucose monitoring device (Free style libre) . • Serum creatinine and calculated eGFR • Lipid profile (total cholesterol, HDL, LDL triglycerids) • urinary Albuminuria/creatinine ratio • HbA1c • CRP

—

Contacts

Public Contactmax nieuwdorp

AMC

m.nieuwdorp@amsterdamumc.nl0031 20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)