Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
polyphenol, transit time
Brief summary
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_SUPPLEMENTOral 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_TESTfasting blood sample
Fasting blood sample will be obtained for determination of markers of metabolic health.
DIAGNOSTIC_TESTFasting 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_TEST24 hours urine collection
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
OTHERQuestionnaires
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_TESTStool collection
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
DIAGNOSTIC_TESTTransit 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.
Sponsors
University Hospital, Ghent
University Ghent
University of Parma
Universiteit Antwerpen
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in polyphenol metabolites in morning urine in persons with type 2 diabetes and in healthy controls. | This will be assessed the morning after ingestion of the pill containing polyphenols | The study aims to characterize the overall polyphenol metabotype in patients with T2DM compared to age-matched individuals without diabetes. For this purpose we will look at morning urine 24h after ingestion of a polyphenol rich pill. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in polyphenol metabolites in 24h urine in persons with type 2 diabetes and in healthy controls. | Urine will be collected over a 24h period after ingestion of the polyphenol pill. | For this purpose participants will collect urine over a 24h period |
| Transit time | baseline | Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool. |
| the capacity of the gut microbiome to degrade polyphenols | baseline | By using a batch experiment. |
| Metabolic health | baseline | This will be determined on the fasting blood samples |
| lifestyle factors and medical history (A) | baseline | physical activity, using the validated IPAQ questionnaire |
| lifestyle factors and medical history (B) | baseline | Sleep, using the validated PSQI questionnaire |
Countries
Belgium
Contacts
CONTACTJan Stautemas, PhD
CONTACTPatrick Calders, Professor
PRINCIPAL_INVESTIGATORBruno Lapauw, Professor
University Hospital, Ghent
Outcome results
None listed