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Completed

NCT Number: NCT00370305

11ß-HSD1 and Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Impaired Glucose Tolerance Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite, Campus Benjamin Franklin

Berlin, 12200, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

89 mg BID for 8 weeks, orally

Other names: Avandia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

The Pathogenic Role of 11ß-hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 31, 2006
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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