Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

• Conditions: Prediabetes

• Registration Number: NCT01869101
• Lead Sponsor: Tethys Bioscience, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study Start: 2013-06
• Study First Posted: 2013-06-05
• Last Update Posted: 2013-06-05
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 560

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes prevention treatment decisions by physician	6 months	The physician's clinical decision (e.g., counseling, referral to dietician, diet and exercise program) at the time of study subject visits will be recorded, summarized descriptively, and ranked in order of intensity based on pre-specified criteria.

Secondary Outcome Measures

Name	Time	Method
Subject initiation and persistence with diabetes prevention interventions	6 months	Whether or not the study subject initiates physician recommended diabetes prevention efforts and study subjects persistence with prevention recommendations will be assessed throughout the 6-month duration of the study.