Status:
UNKNOWN
Effect of Oral 6-bromotryptophan on Safety, Pharmacokinetics and Efficacy in Metabolic Syndrome Individuals
Lead Sponsor:
Nordin Hanssen
Conditions:
Metabolic Syndrome
Diabetes Mellitus
Eligibility:
MALE
35-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Safety, pharmacokinetics and efficacy of a novel endogenous plasma metabolite, 6-bromotryptophan, will be established in metabolic syndrome/ insulin resistant participants.
Detailed Description
Rationale: A newly identified endogenous plasma microbiome-derived tryptophan metabolite, 6-bromotryptophan (6-BT), was associated with preserved beta-cell function and diminished circulating T cell ...
Eligibility Criteria
Inclusion
- • Metabolic syndrome, defined as:
- \- ≥3 criteria out of the 5 following criteria:
- fasting plasma glucose ≥5.6 mmol/L
- triglycerides ≥1.7 mmol/L
- waist circumference ≥102 cm
- high-density lipoprotein cholesterol ≤1.04 mmol/
- blood pressure ≥130/85 mm Hg.
- AND/ OR Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (\>2.5)
- Male
- Caucasian
- 35-70 years old
Exclusion
- Use of systemic medication (except for paracetamol), including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period.
- A history of a cardiovascular event
- A history of cholecystectomy
- Overt untreated gastrointestinal disease or abnormal bowel habits
- Liver enzymes\>2.5 fold higher than the upper limit of normal range
- Smoking
- Exclusion criterion for MRI liver (see E4\_BROMO\_vragenlijst MRI)
- Alcohol abuse
Key Trial Info
Start Date :
May 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05971524
Start Date
May 4 2023
End Date
February 1 2025
Last Update
August 22 2023
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ