11ß-HSD1 and Metabolic Syndrome

Charité University Medicine Berlin

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance; Metabolic Syndrome

Treatments: Drug: rosiglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00370305

ek. 211-02d

Details and patient eligibility

About

The purpose of this study is to determine whether the insulin sensitizing effects of rosiglitazone were accompanied by changes in 11ß-HSD1 expression and activity in different tissues. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in several tissues.

Full description

The PPARgamma agonist rosiglitazone (R) increases insulin sensitivity, which is comparable to the effects of a reduction in 11ß-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activity in animal models. We therefore aimed to investigate whether rosiglitazone-induced insulin sensitivity is associated with changes in 11β-HSD1 activity in different tissues in subjects suffering from impaired glucose tolerance. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in those tissue samples.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Impaired glucose tolerance

Exclusion criteria

• Treatment with insulin
• Orally taken antidiabetic medication, glucocorticoids or vitamin K-antagonists
• Heart failure
• Impaired hepatic or renal function
• Anaemia
• Disturbed coagulation
• Any other endocrine disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Rosiglitazone treatment

Experimental group

Description:

Rosiglitazone will be given to the subjects. All subjects will be analyzed before and after treatment

Treatment:

Drug: rosiglitazone