Bile acid composition and diabetes

Withdrawn

• Conditions: bile acid metabolism; diabetes; 10018424

• Registration Number: NL-OMON33057
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 24

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

- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are changes in bile acid composition</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are changes in hepatic and peripheral insulin resistance<br /><br>(assessed by hyperinsulinemic euglycemic clamp and stable isotopes at baseline<br /><br>and after 12 weeks), metabolic parameters (lipid profile, glycemic control) as<br /><br>well as changes in faecal microbiota, glucose and lipid content (assessed by<br /><br>analysing faeces samples). Finally, muscle and adipose tissue samples will be<br /><br>obtained to assess D2 mRNA and activity and phosphorylation status of the<br /><br>insulin signalling cascade.</p><br>