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

Is the gut microbiome associated with residual beta cell function in longstanding type 1 diabetes? - GUTDM1: Residual beta cell function and microbiome in type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49369

Enrollment

500

Registered

2020-07-03

Start date

2020-11-23

Completion date

Unknown

Last updated

2026-05-11

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

Conditions

Juvenile diabetes type 1 diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 1 diabetes, >18 years old, visit outpatient clinic Amsterdam region, ability to provide informed consent

Exclusion criteria

Exclusion criteria: - Active infection at the time of inclusion (not to influence T-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
2-hour post-meal urinary C-peptide / creatinine ratio as a validated marker of beta cell reserve in type 1 diabetes mellitus.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints • Frequency Hypoglycemia • Awareness hypoglycemia • Diabetic complications • Circulating immune cell pannel • Fecal microbial composition (ILlumina sequencing) • Plasma metabolomics • DNA buffycoat (epigenetics) Other study parameters (covariates and confounders) Derived from the questionnaire: • Sex • Age • Duration of type 1 diabetes • Smoking • Medication use • Diabetic complications Recorded at the study visit • Blood pressure • Body weight • Height • Glucose time in range from continuous glucose monitoring device. In Netherlands these devices are reimbursed for all individuals with T1D. If a participant doesn*t have one a flash glucose monitoring device can be borrowed from the study group, provided by the investigator. Biochemistry • Serum creatinine and calculated eGFR • Lipid profile (total cholesterol, HDL, LDL triglycerids) • Albuminuria/creatinine ratio • HbA1c • CRP	—

Measure

Time frame

Secondary study parameters/endpoints • Frequency Hypoglycemia • Awareness hypoglycemia • Diabetic complications • Circulating immune cell pannel • Fecal microbial composition (ILlumina sequencing) • Plasma metabolomics • DNA buffycoat (epigenetics) Other study parameters (covariates and confounders) Derived from the questionnaire: • Sex • Age • Duration of type 1 diabetes • Smoking • Medication use • Diabetic complications Recorded at the study visit • Blood pressure • Body weight • Height • Glucose time in range from continuous glucose monitoring device. In Netherlands these devices are reimbursed for all individuals with T1D. If a participant doesn*t have one a flash glucose monitoring device can be borrowed from the study group, provided by the investigator. Biochemistry • Serum creatinine and calculated eGFR • Lipid profile (total cholesterol, HDL, LDL triglycerids) • Albuminuria/creatinine ratio • HbA1c • CRP

—

Countries

Netherlands

Outcome results