11ß-HSD1 and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

The Pathogenic Role of 11ß-hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370305
• Other study ID #: ek. 211-02d
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2006
• Last updated: January 11, 2018
• Start date: May 2004
• Est. completion date: October 2008

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• rosiglitazone
89 mg BID for 8 weeks, orally

Locations

Country	Name	City	State
Germany	Charite, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment	11ß-HSD1 expression will be measured in adipose tissue and skeletal muscle	8 weeks
Primary	changes of hepatic 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment	11ß-HSD1 activity will be assessed by measuring conversion of cortisone to cortisol (ratio will be calculated)	8 weeks
Primary	changes of whole body 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment	whole body 11ß-HSD1 activity will be assessed by measuring the ratio of urinary tetrahydrocortisol (THF) + alpha-tetrahydrocortisol (THF) / tetrahydrocortisone	8 weeks
Secondary	changes in insulin sensitivity during 8 weeks of rosiglitazone treatment	Measurement of whole body and myocellular insulin sensitivity (mg•kg-1•min-1/(mU•L-1)) before and after treatment	8 weeks
Secondary	Hormonal and metabolic changes induced by the intervention	Whole body as well as tissue specific (skeletal muscle and different adipose tissue compartment) changes in hormonal circuits and metabolism will be analyzed	3 months
Secondary	changes of FGF-21 induced by the intervention	FGF-21 (ng/ml) will be assessed in plasma samples	8 weeks
Secondary	changes of free fatty acids (FFA) induced by the intervention	FFA (mmol/l) will be assessed in plasma samples	8 weeks
Secondary	changes of myocellular SCD1 expression induced by the intervention	myocellular SCD1 mRNA expression will be assessed	8 weeks
Secondary	changes of myocellular long chain fatty acids (LC-FA) expression induced by the intervention	myocellular LC-FA mRNA expression will be assessed	8 weeks