Polyphenol Metabotypes in People with Diabetes Type 2 (PPPIL)

Ghent University Hospital (UZ)

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Diagnostic Test: Transit time determination; Diagnostic Test: Fasting urine collection; Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL; Other: Questionnaires; Diagnostic Test: 24 hours urine collection; Diagnostic Test: Stool collection; Diagnostic Test: fasting blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT06810635

ONZ-2023-0601

Details and patient eligibility

About

This cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with T2DM in comparison to age-matched individuals without diabetes. Additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all participants
• between 40-85 years
• age-matched individuals without diabetes
• BMI between 18.5-30
• no metabolic syndrome
• persons with T2DM
• at leats 2 years of clinical diagnoses of T2DM
• stable medication use for at least 1 month

Exclusion criteria

• pregnancy of breastfeeding
• in last month
• acute use of anti/pre/probiotics
• start of new drug or dietary supplements
• major changes in diet
• major lifestyle changes
• diseases
• Gastrointestinal diseases (inflammatory bowel disease)
• Bariatric surgery
• Other forms of diabetes (cystic fibrosis/MODY/T1DM)
• Heart problems (NYHA 3/4) or previous cardiovascular events
• Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis
• Lung problems (COPD - GOLD 3/4), cystic fibrosis
• Uncontrolled thyroid function disruption in the past 6 months
• Intake of coumarin derivatives and direct oral anticoagulant medication
• Anti-cancer treatment: chemo-/immunotherapy
• Immonosuppressants (transplant)
• Antiepileptic drugs

Trial design

100 participants in 2 patient groups

T2DM

Description:

persons with type 2 diabetes mellitus

Treatment:

Diagnostic Test: fasting blood sample

Diagnostic Test: Stool collection

Diagnostic Test: 24 hours urine collection

Other: Questionnaires

Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL

Diagnostic Test: Transit time determination

Diagnostic Test: Fasting urine collection

Non diabetic persons

Description:

This cohort is a group without type 2 diabetes or any other chronic illness

Treatment:

Diagnostic Test: fasting blood sample

Diagnostic Test: Stool collection

Diagnostic Test: 24 hours urine collection

Other: Questionnaires

Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL

Diagnostic Test: Transit time determination

Diagnostic Test: Fasting urine collection