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11ß-HSD1 and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00370305
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Joachim Spranger, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Impaired Glucose Tolerance Drug: rosiglitazone Phase 2

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. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in those tissue samples.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : May 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008


Arm Intervention/treatment
Experimental: Rosiglitazone treatment
Rosiglitazone will be given to the subjects. All subjects will be analyzed before and after treatment
Drug: rosiglitazone
89 mg BID for 8 weeks, orally
Other Name: Avandia



Primary Outcome Measures :
  1. changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment [ Time Frame: 8 weeks ]
    11ß-HSD1 expression will be measured in adipose tissue and skeletal muscle

  2. changes of hepatic 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment [ Time Frame: 8 weeks ]
    11ß-HSD1 activity will be assessed by measuring conversion of cortisone to cortisol (ratio will be calculated)

  3. changes of whole body 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment [ Time Frame: 8 weeks ]
    whole body 11ß-HSD1 activity will be assessed by measuring the ratio of urinary tetrahydrocortisol (THF) + alpha-tetrahydrocortisol (THF) / tetrahydrocortisone


Secondary Outcome Measures :
  1. changes in insulin sensitivity during 8 weeks of rosiglitazone treatment [ Time Frame: 8 weeks ]
    Measurement of whole body and myocellular insulin sensitivity (mg•kg−1•min−1/(mU•L−1)) before and after treatment

  2. Hormonal and metabolic changes induced by the intervention [ Time Frame: 3 months ]
    Whole body as well as tissue specific (skeletal muscle and different adipose tissue compartment) changes in hormonal circuits and metabolism will be analyzed

  3. changes of FGF-21 induced by the intervention [ Time Frame: 8 weeks ]
    FGF-21 (ng/ml) will be assessed in plasma samples

  4. changes of free fatty acids (FFA) induced by the intervention [ Time Frame: 8 weeks ]
    FFA (mmol/l) will be assessed in plasma samples

  5. changes of myocellular SCD1 expression induced by the intervention [ Time Frame: 8 weeks ]
    myocellular SCD1 mRNA expression will be assessed

  6. changes of myocellular long chain fatty acids (LC-FA) expression induced by the intervention [ Time Frame: 8 weeks ]
    myocellular LC-FA mRNA expression will be assessed



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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


Locations
Germany
Charite, Campus Benjamin Franklin
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Knut Mai Charite, Dpt. of Endocrinology, Diabetes and Nutrition

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Joachim Spranger, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00370305     History of Changes
Other Study ID Numbers: ek. 211-02d
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

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

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