Phielix et al.: Hepatic Fat Content and Adipokines

NCT ID: NCT01570660

Last Updated: 2012-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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control group

parallel group without intervention

Group Type NO_INTERVENTION

Pioglitazone

Intervention Type DRUG

12 weeks of pioglitazone treatment

Interventions

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Pioglitazone

12 weeks of pioglitazone treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Roden, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 23574533 (View on PubMed)

Other Identifiers

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26/2002

Identifier Type: REGISTRY

Identifier Source: secondary_id

026/2002

Identifier Type: -

Identifier Source: org_study_id

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