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

Intestinal production of Imidazole Propionate in healthy and obese subjects with or without DM2; a pilot trial - IP-pilot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44179
Enrollment
6
Registered
2017-09-13
Start date
2018-02-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes Diabetes mellitus

Interventions

Gut microbiota
Imidazole propionate
Diabetes mellitus
We will orally administrate labelled histidine twice (either using gelatin capsules that are releasing histidine in the small intestine versus ColoPulse-capsules that release histidine in the colon)

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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 102 cm, HDL-cholesterol 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

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

Design outcomes

Primary

MeasureTime frame
Primary objective will be determination of plasma and 24h fecal concentrations of labelled L-histidine and its degradation products, urocanate, IP and glutamate upon either ingestion of gelatin capsules (thus small intestinal release) or colopulse capsules (colonic release).

Secondary

MeasureTime frame
Secondary objective will be differences in uptake and production between subjects with a normal and impaired insulin sensitivity as well as in DM2 subjects on stable dose of oral metformin in relation to fecal microbiota composition.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)