NCT00370305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

4.4 years

First QC Date

August 30, 2006

Last Update Submit

January 11, 2018

Conditions

Metabolic SyndromeImpaired Glucose Tolerance

Keywords

11ß-hydroxysteroid dehydrogenaserosiglitazoneinsulin sensitivityImpaired glucose tolerance

Outcome Measures

Primary Outcomes (3)

  • 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

    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)

    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

    8 weeks

Secondary Outcomes (6)

  • changes in insulin sensitivity during 8 weeks of rosiglitazone treatment

    8 weeks

  • Hormonal and metabolic changes induced by the intervention

    3 months

  • changes of FGF-21 induced by the intervention

    8 weeks

  • changes of free fatty acids (FFA) induced by the intervention

    8 weeks

  • changes of myocellular SCD1 expression induced by the intervention

    8 weeks

  • +1 more secondary outcomes

Study Arms (1)

Rosiglitazone treatment

EXPERIMENTAL

Rosiglitazone will be given to the subjects. All subjects will be analyzed before and after treatment

Drug: rosiglitazone

Interventions

rosiglitazoneDRUG

89 mg BID for 8 weeks, orally

Also known as: Avandia
Rosiglitazone treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired glucose tolerance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21741058DERIVED

MeSH Terms

Conditions

Metabolic SyndromeGlucose IntoleranceInsulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Knut Mai

    Charite, Dpt. of Endocrinology, Diabetes and Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

May 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

DE(1)