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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by German Diabetes Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014