Clinical trial NCT00370305: 11ß-HSD1 and Metabolic Syndrome
Official title: The Pathogenic Role of 11ß-hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Impaired Glucose Tolerance
Keywords: 11ß-hydroxysteroid dehydrogenase
rosiglitazone
insulin sensitivity
Impaired glucose tolerance
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2006-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment
timeFrame: 8 weeks
measure: changes of hepatic 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment
timeFrame: 8 weeks
measure: changes of whole body 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: changes in insulin sensitivity during 8 weeks of rosiglitazone treatment
timeFrame: 8 weeks
measure: Hormonal and metabolic changes induced by the intervention
timeFrame: 3 months
measure: changes of FGF-21 induced by the intervention
timeFrame: 8 weeks
measure: changes of free fatty acids (FFA) induced by the intervention
timeFrame: 8 weeks
measure: changes of myocellular SCD1 expression induced by the intervention
timeFrame: 8 weeks
measure: changes of myocellular long chain fatty acids (LC-FA) expression induced by the intervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin
Study officials:
affiliation: Charite, Dpt. of Endocrinology, Diabetes and Nutrition
name: Knut Mai
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.