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

Completed

Conditions: diabetes mellitus
sugar disease
10018424
10012653

Registration Number: NL-OMON54977

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

Healthy subjects: (n=11 Caucasian and n=11 from South Asian Surinamese descent)
- Healthy subjects 40-70 years,
- BMI 19-25
T2D subjects:(n=11 Caucasian and n=11 from South Asian Surinamese descent)
- T2D patients
- Caucasian / South Asian Surinamese
- 40-70 years
- BMI 25-35
- Stable anti-diabetic drugs for 3 months (metformin is obligatory)
- Statin use
- Stable medication use past 3 months
- Able to give informed consent

Exclusion Criteria

All participants:
- Previous major cardiovascular event (e.g. AMI/stroke/TIA)
- Proton-pomp inhibitor use
- GLP1 or insulin
- Antibiotics use for the past 3 months
- Probiotic of 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
- Vegetarian diet
- >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
<p>Primary objective will be determination of ImP levels after histidine intake<br /><br>and other degradation products such as urocanate and glutamate before and after<br /><br>oral antibiotics. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives will be differences in histidine uptake effect upon oral<br /><br>histidine supplementation on PBMC inflammatory status, influence of gut<br /><br>microbiome on ImP production, continuous (freestyle libre) as well as<br /><br>postprandial (after a mixed meal test) glucose levels between healthy and T2D<br /><br>subjects on stable dose of oral metformin. Furthermore, we will evalualte if<br /><br>the kinetics and other mentioned parameters are affected differently between<br /><br>ethnicities by histidine intake.</p><br>