Intestinal production of Imidazole Propionate in healthy and obese subjects with or without DM2; <br>a pilot trial<br>

Completed

Conditions: diabetes
Diabetes mellitus
10018424
10000546

Registration Number: NL-OMON44179

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

All subjects: age 18-54 years old, caucasian male, able to give informed consent;- Healthy controls: Subjects do not meet the criteria for metabolic syndrome or diabetes type 2, BMI <25 kg/m2
- Metabolic syndrome subjects: at least 3 out of 5 NCEP metabolic syndrome criteria (fasting plasma glucose * 5.6 mmol/l OR HOMA * 2.5, triglycerides * 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol < 1.04 mmol/l, blood pressure * 130/85 mmHg).
- DM2 subjects: must meet the criteria for DM2: a random blood glucose level of >11.1 mmol/L and/or a fasting blood glucose level of >7.0 mmol/L and/or a blood sugar glucose of >11.1mmol/L two hours after an oral glucose toleralance test and/or an HbA1c of >47mmol/mol. Stable metformin use for at least 1 month (preferably 3dd 500mg)

Exclusion Criteria

All subjects:
- Cholecystectomy
- A history of cardiovascular event (MI or pacemaker implantation)
- Use of medication in the last three months with the exception of metformin for DM2 subjects
- (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
- Smoking, drugs- or alcohol abuse

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective will be determination of plasma and 24h fecal concentrations<br /><br>of labelled L-histidine and its degradation products, urocanate, IP and<br /><br>glutamate upon either ingestion of gelatin capsules (thus small intestinal<br /><br>release) or colopulse capsules (colonic release). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective will be differences in uptake and production between<br /><br>subjects with a normal and impaired insulin sensitivity as well as in DM2<br /><br>subjects on stable dose of oral metformin in relation to fecal microbiota<br /><br>composition.</p><br>