- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370305
11ß-HSD1 and Metabolic Syndrome
January 11, 2018 updated by: Professor Joachim Spranger, Charite University, Berlin, Germany
The Pathogenic Role of 11ß-hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Berlin, Germany, 12200
- Charite, Campus Benjamin Franklin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosiglitazone treatment
Rosiglitazone will be given to the subjects.
All subjects will be analyzed before and after treatment
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89 mg BID for 8 weeks, orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment
Time Frame: 8 weeks
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11ß-HSD1 expression will be measured in adipose tissue and skeletal muscle
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8 weeks
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changes of hepatic 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment
Time Frame: 8 weeks
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11ß-HSD1 activity will be assessed by measuring conversion of cortisone to cortisol (ratio will be calculated)
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8 weeks
|
changes of whole body 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment
Time Frame: 8 weeks
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whole body 11ß-HSD1 activity will be assessed by measuring the ratio of urinary tetrahydrocortisol (THF) + alpha-tetrahydrocortisol (THF) / tetrahydrocortisone
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8 weeks
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Hormonal and metabolic changes induced by the intervention
Time Frame: 3 months
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Whole body as well as tissue specific (skeletal muscle and different adipose tissue compartment) changes in hormonal circuits and metabolism will be analyzed
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3 months
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changes of FGF-21 induced by the intervention
Time Frame: 8 weeks
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FGF-21 (ng/ml) will be assessed in plasma samples
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8 weeks
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changes of free fatty acids (FFA) induced by the intervention
Time Frame: 8 weeks
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FFA (mmol/l) will be assessed in plasma samples
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8 weeks
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changes of myocellular SCD1 expression induced by the intervention
Time Frame: 8 weeks
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myocellular SCD1 mRNA expression will be assessed
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8 weeks
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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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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Knut Mai, Charité, Dpt. of Endocrinology, Diabetes and Nutrition
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
August 30, 2006
First Submitted That Met QC Criteria
August 30, 2006
First Posted (Estimate)
August 31, 2006
Study Record Updates
Last Update Posted (Actual)
January 16, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ek. 211-02d
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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