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11ß-HSD1 and Metabolic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: August 31, 2006
Last Update Posted: May 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
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.

Condition Intervention Phase
Metabolic Syndrome Impaired Glucose Tolerance Drug: rosiglitazone Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pathogenic Role of 11ß-Hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • changes in total, hepatic, adipose and muscular 11ß-HSD1 activity after 8 weeks
  • changes in 11ß-HSD1 expression in adipose tissue and and skeletal muscles after 8 weeks

Secondary Outcome Measures:
  • changes in insulin sensitivity after 8 weeks

Estimated Enrollment: 7
Study Start Date: May 2004
Detailed 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370305

Contact: Knut Mai +49-30-8445-2114 knutmai@charite.de
Contact: Sven Diederich, PD +49-30-20915631 sven.diederich@endokrinologikum.de

Charite, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Knut Mai    +49-30-84452114    knut.mai@charite.de   
Principal Investigator: Knut Mai         
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Knut Mai Charite, Dpt. of Endocrinology, Diabetes and Nutrition
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370305     History of Changes
Other Study ID Numbers: ek. 211-02d
First Submitted: August 30, 2006
First Posted: August 31, 2006
Last Update Posted: May 14, 2007
Last Verified: May 2007

Keywords provided by Charite University, Berlin, Germany:
11ß-hydroxysteroid dehydrogenase
insulin sensitivity
Impaired glucose tolerance

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Intolerance
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs