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Completed

NCT Number: NCT01570660

Phielix et al.: Hepatic Fat Content and Adipokines

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

12 weeks of pioglitazone treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2012
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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