Polyphenol Metabotypes in People With Diabetes Type 2
Recruiting · NCT06810635 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Ghent
View the official record on ClinicalTrials.gov →Interventions studied
24 hours urine collectionFasting urine collectionOral Polyphenol Challenge Test / PPPILQuestionnairesStool collectionTransit time determinationfasting blood sample
What this trial is 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).
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Department of rehabilitation sciences - UGent - Ghent, Belgium
- Ghent University - Ghent, East Flanders, Belgium