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Recruiting NCT06810635

Polyphenol Metabotypes in People With Diabetes Type 2

— Observational Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Polyphenol Challenge Test / PPPIL, fasting blood sample, Fasting urine collection, 24 hours urine collection.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Dietary supplement Oral Polyphenol Challenge Test / PPPIL
    Patients will receive a so-called oral polyphenol challenge test. It is a pill containing a multitude of polyphenol classes (doi: 10.1093/cdn/nzac072.020)
  • Diagnostic test fasting blood sample
    Fasting blood sample will be obtained for determination of markers of metabolic health.
  • Diagnostic test Fasting urine collection
    Subjects collect morning urine (or the urine thereafter ) in a separate urine container and write down the time of urine collection for determination of polyphenol metabolites
  • Diagnostic test 24 hours urine collection
    Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
  • Other Questionnaires
    Questionnaires will be performed to collect information on lifestyle and baseline characteristics: physical activity (IPAQ), sleep (PSQI), drinking and smoking behaviour, drug intake and medical record.
  • Diagnostic test Stool collection
    Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
  • Diagnostic test Transit time determination
    Subjects take a pill containing 90mg of royal blue dye (E133) together with the polyphenol pill to determine their transit time. When their stool discolours, the subjects notify the researcher.

Primary outcome measures

  • Differences in polyphenol metabolites in morning urine in persons with type 2 diabetes and in healthy controls. [Time frame: This will be assessed the morning after ingestion of the pill containing polyphenols]
Secondary outcome measures (6)
  • Differences in polyphenol metabolites in 24h urine in persons with type 2 diabetes and in healthy controls. [Time frame: Urine will be collected over a 24h period after ingestion of the polyphenol pill.]
  • Transit time [Time frame: baseline]
  • the capacity of the gut microbiome to degrade polyphenols [Time frame: baseline]
  • Metabolic health [Time frame: baseline]
  • lifestyle factors and medical history (A) [Time frame: baseline]
  • lifestyle factors and medical history (B) [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Belgium · 2 centers
  • Ghent University — Ghent
  • Department of rehabilitation sciences - UGent — Ghent

Identifiers

NCT: NCT06810635 · ONZ-2023-0601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗