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Beta cell inflammation in type 2 diabetes caused by bacterial translocation; the BETA-BACT study

Beta cell inflammation in type 2 diabetes caused by bacterial translocation; the BETA-BACT study - BETA-BACT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42545
Enrollment
20
Registered
2015-06-11
Start date
2015-06-28
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

insulin resistance Type 2 diabetes

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients: - Caucasian male or female - A history of T2D as defined by: 1. previous fasting glucose >7.0 mmol/l and fasting glucose >7.0 mmol/l on the day of surgery; OR (previous) HbA1C >48mmol/l; OR 3. use of antidiabetic medication - Scheduled for pancreatic surgery because of pancreatic carcinoma - Subjects should be able to give informed consent;Non-diabetic participants: - fasting plasma glucose

Exclusion criteria

Exclusion criteria: Type 2 diabetes patients: - Use of antibiotics in the past 3 months - Chronic alcohol use - Use of GLP-1 receptor agonists or DPP-4 inhibitors - Inability to understand the study protocol;Non-diabetic participants: - A history of T2D or type 1 diabetes (T1D) - Use of antibiotics in the past 3 months

Design outcomes

Primary

MeasureTime frame
Our primary endpoint is the amount of bacterial DNA in pancreatic beta cell tissue.

Secondary

MeasureTime frame
As a secondary endpoint, we will assess fecal and oral microbiota composition and relate this to pancreatic microbiota composition, concentration of bacterial metabolites in pancreatic tissue and markers of inflammation expressed in pancreatic tissue and plasma. Finally, we will study beta cell function ex vivo by culturing beta cells obtained during surgery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)