Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes
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|ClinicalTrials.gov Identifier: NCT01869101|
Recruitment Status : Unknown
Verified May 2013 by Tethys Bioscience, Inc..
Recruitment status was: Not yet recruiting
First Posted : June 5, 2013
Last Update Posted : June 5, 2013
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||560 participants|
|Observational Model:||Case Control|
|Official Title:||A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
- Diabetes prevention treatment decisions by physician [ Time Frame: 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.
- Subject initiation and persistence with diabetes prevention interventions [ Time Frame: 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.
- fasting glucose [ Time Frame: 6 months ]
- Hemoglobin A1C [ Time Frame: 6 months ]
- Blood pressure [ Time Frame: 6 months ]
- Body weight [ Time Frame: 6 months ]
- BMI [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869101
|Contact: Christine A. Towey, BAfirstname.lastname@example.org|
|Study Director:||Juan P. Frias, M.D.||Tethys Bioscience|
|Study Chair:||David G Marrero, Ph.D.||Indiana University School of Medicine|