11ß-HSD1 and Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00370305
First received: August 30, 2006
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370305

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

Locations
Germany
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
Investigators
Principal Investigator: Knut Mai Charite, Dpt. of Endocrinology, Diabetes and Nutrition
  More Information

No publications provided by Charite University, Berlin, Germany

Additional 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
Study First Received: August 30, 2006
Last Updated: May 11, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Glucose Intolerance
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperglycemia
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014