Phielix et al.: Hepatic Fat Content and Adipokines
Effects of Glimepiride Monotherapy Versus Combined Neteglinide-Pioglitazone Therapy on Insulin Sensitivity in Type 2 Diabetic Patients
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Feb 2002
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedApril 4, 2012
April 1, 2012
10.1 years
March 14, 2012
April 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (1)
intrahepatocellular lipid content
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.
Study Arms (1)
control group
NO INTERVENTIONparallel group without intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Austria
Related Publications (1)
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.
PMID: 23574533DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2012
First Posted
April 4, 2012
Study Start
February 1, 2002
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 4, 2012
Record last verified: 2012-04