- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01570660
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
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
-
-
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Vienna, Austria
- Medical University of Vienna
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-
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.
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Participants underwent a two-step hyperinsulinemic euglycemic clamp to determine insulin sensitivity, expressed as rate of glucose disposal (Rd) in mg/kg/min.
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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).
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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