diabetes Diabetes mellitus
Conditions
Interventions
Participants will be given placebo, 2mg, 4mg or 8mg of 6-BT capsules once daily
for 4 weeks (n=9 per arm, total of 36 participants).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Metabolic syndrome AND/OR insulin resistance, defined as: * Metabolic syndrome: >=3 criteria out of the 5 following criteria: o fasting plasma glucose >=5.6*mmol/L o triglycerides >=1.7*mmol/L o waist circumference >=102*cm o high-density lipoprotein cholesterol =130/85*mm Hg. * Insulin resistance: HOMA-IR (>2.5) • Male • Caucasian • 35-70 years old
Exclusion criteria
Exclusion criteria: - 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 - Alcohol abuse - Exclusion criterion for MRI liver (metal in body, claustrophobic etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal outcome will be patient safety and tolerability (biochemical parameters of kidney and liver function and complete blood count, adverse events) in relation to improvements in glucose homeostasis (mixed-meal tests and continuous glucose monitoring). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary read-outs will include changes in: immunological profile (ex vivo stimulation of monocytes, and immunophenotyping of peripheral blood mononuclear cells (PBMC)) and gut microbiome composition (16s rRNA sequencing). Also, liver fat content will be determined before and at end of the trial by MRI. As this food derived metabolite is given to humans for the first time, we will also study its pharmacokinetics by measuring serum 6-BT concentrations in serum and urine at different time-points after oral intake. | — |
Countries
Netherlands
Outcome results
None listed