Phielix et al.: Hepatic Fat Content and Adipokines

April 2, 2012 updated by: German Diabetes Center

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
parallel group without intervention
12 weeks of pioglitazone treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants underwent a two-step hyperinsulinemic euglycemic clamp to determine insulin sensitivity, expressed as rate of glucose disposal (Rd) in mg/kg/min.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Liver proton-magnetic resonance spectroscopy was applied to determine liver fat (HCL) in % (relative to the water peak).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 2, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 026/2002
  • 26/2002 (Registry Identifier: Ethikkommisson)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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