Back to resultsPhielix et al.: Hepatic Fat Content and Adipokines
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
control group
Arm Description
parallel group without intervention
Outcomes
Primary Outcome Measures
whole body insulin sensitivity
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
Liver proton-magnetic resonance spectroscopy was applied to determine liver fat (HCL) in % (relative to the water peak).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01570660
Brief Title
Phielix et al.: Hepatic Fat Content and Adipokines
Official Title
Effects of Glimepiride Monotherapy Versus Combined Neteglinide-Pioglitazone Therapy on Insulin Sensitivity in Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Diabetes Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
parallel group without intervention
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
12 weeks of pioglitazone treatment
Primary Outcome Measure Information:
Title
whole body insulin sensitivity
Description
Participants underwent a two-step hyperinsulinemic euglycemic clamp to determine insulin sensitivity, expressed as rate of glucose disposal (Rd) in mg/kg/min.
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.
Secondary Outcome Measure Information:
Title
intrahepatocellular lipid content
Description
Liver proton-magnetic resonance spectroscopy was applied to determine liver fat (HCL) in % (relative to the water peak).
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Roden, Prof.
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
23574533
Citation
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.
Results Reference
derived
Learn more about this trial
Phielix et al.: Hepatic Fat Content and Adipokines
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