The effect of a bile acid sequestrant on bile acid- and glucose metabolism in patients with impaired glucose tolerance.

Altered Bile Acid Composition And Diabetes: Analysing Basic Relational Aspects; the ABACADABRA study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24802

Enrollment

Registered

2009-04-03

Start date

2009-05-01

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 mellitus type 2, bile acid metabolism

Interventions

Patients will be randomised to either colesevelam treatment or placebo treatment for a period of 12 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male obese subjects with an impaired glucose tolerance or newly diagnosed type 2 diabetes mellitus (fasting glucose > 6,0 mmol/l); 2. Age 18-55 yr; 3. BMI>30 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Medication known to interfere with glucose metabolism or bowel flora composition; 2. Severe hypertriglyceridemia or any other lipid metabolism disorder; 3. Intensive sports (> three times weekly).

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 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.	—

Measure

Time frame

Secondary endpoints are changes in hepatic and peripheral insulin resistance (assessed by hyperinsulinemic euglycemic clamp 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.

—

Contacts

Public ContactA. Vrieze

PO Box 22660

a.vrieze@amc.uva.nl+31 (0)20 5665983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)