Phielix et al.: Hepatic Fat Content and Adipokines

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of Glimepiride Monotherapy Versus Combined Neteglinide-Pioglitazone Therapy on Insulin Sensitivity in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570660
• Other study ID #: 026/2002
• Secondary ID: 26/2002
• Status: Completed
• Phase: N/A
• First received: March 14, 2012
• Last updated: April 2, 2012
• Start date: February 2002
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: German Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Pioglitazone
12 weeks of pioglitazone treatment

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
German Diabetes Center

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	intrahepatocellular lipid content	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.	No