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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
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Drug: Pioglitazone

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Glimepiride Monotherapy Versus Combined Neteglinide-Pioglitazone Therapy on Insulin Sensitivity in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 24
Study Start Date: February 2002
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
parallel group without intervention
 Drug: Pioglitazone
12 weeks of pioglitazone treatment

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570660

Locations
Austria
Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
German Diabetes Center
Investigators
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
  More Information

No publications provided

Responsible Party: German Diabetes Center
ClinicalTrials.gov Identifier: NCT01570660     History of Changes
Other Study ID Numbers: 026/2002, 26/2002
Study First Received: March 14, 2012
Last Updated: April 2, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013