Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

NCT ID: NCT01869101

Last Updated: 2013-06-05

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

UNKNOWN

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.

Detailed Description

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Conditions

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Prediabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Diagnosis of prediabetes based on hemoglobin A1C and/or fasting plasma glucose
* Established patient of Principal Investigator's clinical practice
* BMI greater than or equal to 25 kg/m2
* Physically able to participate in a diabetes prevention program

Exclusion Criteria

* Has prior diagnosis of diabetes
* Is pregnant or is planning to become pregnant in the next 6 months
* Is currently taking a medication prescribed for diabetes prevention
* Is currently enrolled in a formal diabetes prevention or weight loss program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tethys Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan P. Frias, M.D.

Role: STUDY_DIRECTOR

Tethys Bioscience

David G Marrero, Ph.D.

Role: STUDY_CHAIR

Indiana University School of Medicine

Central Contacts

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Christine A. Towey, BA

Role: CONTACT

760-520-0394

Other Identifiers

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TET2013-001

Identifier Type: -

Identifier Source: org_study_id

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