Polyphenol Metabotypes in People with Diabetes Type 2

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06810635
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-06
• Status Verified: 2025-01
• Study Start: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2028-11
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, East Flanders, Belgium