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Pioglitazone on Pancreatic Steatosis and Bone Health

NCT ID: NCT00855010

Last Updated: 2017-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-12-31

Brief Summary

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Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes

Keywords

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Pioglitazone prediabetes diabetes obesity Pancreatic fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pioglitazone

pioglitazone tablet 45 mg once daily

Group Type EXPERIMENTAL

pioglitazone

Intervention Type DRUG

pioglitazone 45 mg daily

placebo pill

placebo pill once daily (look-alike pill which contains no active ingredients)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one daily

Interventions

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pioglitazone

pioglitazone 45 mg daily

Intervention Type DRUG

placebo

one daily

Intervention Type DRUG

Other Intervention Names

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Actos Placebo tablet resembling pioglitazone 45 mg.

Eligibility Criteria

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Inclusion Criteria

* Fat level in the pancreas above 4% (measurement done by us with an MRI)
* English speaker
* over 21 years old

Exclusion Criteria

* contraindication to MRI
* anemia
* pregnancy or desire to conceive
* use of unapproved medications
* prior pancreatic disease
* use of more then 2 alcoholic drinks every day
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ildiko Lingvay

MD, MPH, MSCS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1K23RRO24470-01

Identifier Type: -

Identifier Source: secondary_id

112008-047

Identifier Type: -

Identifier Source: org_study_id

NCT00896116

Identifier Type: -

Identifier Source: nct_alias