Intestinal imidazole propioNaTE productioN after histiDinE supplementation in healthy and type 2 Diabetes mellitus subjects: role of the gut microbiota

Completed

Conditions: Type 2 diabetes

Registration Number: NL-OMON20133

Lead Sponsor: /A

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

Healthy controls:
-22 healthy controls 40-70 years, BMI <30kg/m2
- 11 controls of Caucasian descent and 11 of Surinamese descent

Type 2 Diabetes (T2D) subjects:
-22 T2D patients (11 of Caucasian descent and 11 of Surinamese descent)
-40-70 years
-BMI 25-35
-Stable anti diabetic drugs for 3 months (metformin is obligatory)
-All on statin
-Stable medication uses past 3 months
-Able to give informed consent

Exclusion Criteria

-Previous major cardiovascular event (e.g. AMI/stroke/TIA)
-PPI
-GLP1 nor insulin
-antibiotic use in the past 3 months
-Probiotic or symbiotic usage
-Pregnant women,
-Chronic illness (including a known history of heart failure, renal failure (eGFR <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
-Active infection,
-Previous intestinal (e.g., bowel resection/reconstruction) surgery
-Smoking (can also influence microbiota)
-Vegetarian diet (since they have different microbiota)
->6 alcohol units per day or >14 alcohol units per week
-Active malignancy
-HbA1c >9% (75mmol/mol)
-The subject is already involved in a clinical trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate ImP, urocanate, glutamate and histamine plasma level excursions upon 4 grams of histidine supplementation before, during and after a short course of oral antibiotics in T2D and healthy controls of Caucasian and Surinamese ethnicity.

Secondary Outcome Measures