Metabolic SyndromePhase 2NCT00370305
11ß-HSD1 and Metabolic Syndrome
A Phase 2 study testing rosiglitazone in people with Metabolic Syndrome and Impaired Glucose Tolerance, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Impaired Glucose Tolerance
- What is being tested?
- rosiglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome, Impaired Glucose Tolerance
- Being tested
- rosiglitazone
- Keywords
- 11ß-hydroxysteroid dehydrogenase, rosiglitazone, insulin sensitivity, Impaired glucose tolerance
- Medical subject headings
- Metabolic Syndrome, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
Also called Avandia
89 mg BID for 8 weeks, orally
| Study group | Role | What they receive |
|---|---|---|
| Rosiglitazone treatment | Experimental | Rosiglitazone will be given to the subjects. All subjects will be analyzed before and after treatment Receives: Drug: rosiglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
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)
Measured: 8 weeks
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
Measured: 8 weeks
Secondary outcomes (6)
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
Measured: 8 weeks
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
Measured: 3 months
changes of FGF-21 induced by the intervention
FGF-21 (ng/ml) will be assessed in plasma samples
Measured: 8 weeks
changes of free fatty acids (FFA) induced by the intervention
FFA (mmol/l) will be assessed in plasma samples
Measured: 8 weeks
changes of myocellular SCD1 expression induced by the intervention
myocellular SCD1 mRNA expression will be assessed
Measured: 8 weeks
changes of myocellular long chain fatty acids (LC-FA) expression induced by the intervention
myocellular LC-FA mRNA expression will be assessed
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startMay 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Joachim Spranger, Charite University, Berlin, Germany
- Investigators
- Knut Mai, Principal investigator, Charite, Dpt. of Endocrinology, Diabetes and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370305
- Sponsor's protocol ID
- ek. 211-02d
- Status last verified
- Jan 2018
- First submitted
- 30 Aug 2006
- Last updated
- 16 Jan 2018
- Results posted
- No
Publications
Mai K, Andres J, Bobbert T, Assmann A, Biedasek K, Diederich S, Graham I, Larson TR, Pfeiffer AF, Spranger J. Rosiglitazone increases fatty acid Delta9-desaturation and decreases elongase activity index in human skeletal muscle in vivo. Metabolism. 2012 Jan;61(1):108-16. doi: 10.1016/j.metabol.2011.05.018. Epub 2011 Jul 7.
PubMed 21741058
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenic Role of 11ß-hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone
- ClinicalTrials.gov ID
- NCT00370305
- Acronym / sponsor ID
- ek. 211-02d
- Conditions
- Metabolic Syndrome, Impaired Glucose Tolerance
- Keywords
- 11ß-hydroxysteroid dehydrogenase, rosiglitazone, insulin sensitivity, Impaired glucose tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 31 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosiglitazone treatment | Experimental | Drug: rosiglitazoneRosiglitazone will be given to the subjects. All subjects will be analyzed before and after treatment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Impaired glucose tolerance
Key exclusion criteria (7 listed)
- Treatment with insulin
- Orally taken antidiabetic medication, glucocorticoids or vitamin K-antagonists
- Heart failure
- Impaired hepatic or renal function
- Anaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazoneAlso: Avandia89 mg BID for 8 weeks, orally | Drug | Rosiglitazone treatment |
Primary outcome
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
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)
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
6 secondary outcomes
changes in insulin sensitivity during 8 weeks of rosiglitazone treatment
Time frame: 8 weeks
Hormonal and metabolic changes induced by the intervention
Time frame: 3 months
changes of FGF-21 induced by the intervention
Time frame: 8 weeks
changes of free fatty acids (FFA) induced by the intervention
Time frame: 8 weeks
changes of myocellular SCD1 expression induced by the intervention
Time frame: 8 weeks
changes of myocellular long chain fatty acids (LC-FA) expression induced by the intervention
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Derived from this study: PubMed 21741058Mai K, Andres J, Bobbert T, Assmann A, Biedasek K, Diederich S, Graham I, Larson TR, Pfeiffer AF, Spranger J. Rosiglitazone increases fatty acid Delta9-desaturation and decreases elongase activity index in human skeletal muscle in vivo. Metabolism. 2012 Jan;61(1):108-16. doi: 10.1016/j.metabol.2011.05.018. Epub 2011 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Mai principal investigator
Charite, Dpt. of Endocrinology, Diabetes and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosiglitazone in people with Metabolic Syndrome and Impaired Glucose Tolerance, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.