Phielix et al.: Hepatic Fat Content and Adipokines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01570660
First received: March 14, 2012
Last updated: April 2, 2012
Last verified: April 2012

March 14, 2012
April 2, 2012
February 2002
March 2012   (final data collection date for primary outcome measure)
whole body insulin sensitivity [ Time Frame: within a minimal of 1 week before the start of the 12 weeks pioglitazone or glimepiride treatment and after the last day of the treatment period. ] [ Designated as safety issue: No ]
Participants underwent a two-step hyperinsulinemic euglycemic clamp to determine insulin sensitivity, expressed as rate of glucose disposal (Rd) in mg/kg/min.
Same as current
Complete list of historical versions of study NCT01570660 on ClinicalTrials.gov Archive Site
intrahepatocellular lipid content [ Time Frame: within a minimal of 1 week before the start of the 12 weeks pioglitazone or glimepiride treatment and after the last day of the treatment period. ] [ Designated as safety issue: No ]
Liver proton-magnetic resonance spectroscopy was applied to determine liver fat (HCL) in % (relative to the water peak).
Same as current
Not Provided
Not Provided
 
Phielix et al.: Hepatic Fat Content and Adipokines
Effects of Glimepiride Monotherapy Versus Combined Neteglinide-Pioglitazone Therapy on Insulin Sensitivity in Type 2 Diabetic Patients

Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as mediators.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
Drug: Pioglitazone
12 weeks of pioglitazone treatment
No Intervention: control group
parallel group without intervention
Intervention: Drug: Pioglitazone
Phielix E, Brehm A, Bernroider E, Krssak M, Anderwald CH, Krebs M, Schmid AI, Nowotny P, Roden M. Effects of pioglitazone versus glimepiride exposure on hepatocellular fat content in type 2 diabetes. Diabetes Obes Metab. 2013 Oct;15(10):915-22. doi: 10.1111/dom.12112. Epub 2013 May 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • well controlled patients with type 2 diabetes (Hb1Ac < 8%)
  • no insulin therapy
  • no co-morbidities
  • stable medication use for the last 6 months
  • stable body weight the last 6 months
  • no diet in the last 6 months

Exclusion Criteria:

  • Hb1Ac > 8%
  • insulin therapy
  • diabetes-related co-morbidities, like cardiovascular disease, neuropathology
  • unstable medication use
  • unstable body weight in the last 6 months (> 5 kg)
  • following a diet in the last 6 months
Both
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01570660
026/2002, 26/2002
No
German Diabetes Center
German Diabetes Center
Not Provided
Principal Investigator: Michael Roden, Prof. Institute for Clinical Diabetology, German Diabetes Center, D-40225, Düsseldorf, Germany; Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. Department of Metabolic Diseases, Un
German Diabetes Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP