bile acid metabolism diabetes
Conditions
Interventions
Patients will be randomised to either colesevelam treatment or placebo
treatment for a period of 12 weeks
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male subjects with an impaired fasting glucose or newly diagnosed type 2 diabetes (fasting plasma glucose> 6.0), 18 to 55 years-old and body mass index (BMI) >30 kg/m2.
Exclusion criteria
Exclusion criteria: - Patients with medication known to interfere with glucose metabolism or gut microbiota composition (antibiotics, sequestrants, chenodiole, ursochol) - Patients with severe hypertriglyceridemia or any other primary lipid disorder. - Patients who practice intensive sports (>three times weekly endurance exercise) - Patients with thyroid diseases (TSH is measured at screening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are changes in bile acid composition | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are changes in hepatic and peripheral insulin resistance (assessed by hyperinsulinemic euglycemic clamp and stable isotopes at baseline and after 12 weeks), metabolic parameters (lipid profile, glycemic control) as well as changes in faecal microbiota, glucose and lipid content (assessed by analysing faeces samples). Finally, muscle and adipose tissue samples will be obtained to assess D2 mRNA and activity and phosphorylation status of the insulin signalling cascade. | — |
Countries
Netherlands
Outcome results
None listed