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Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Tethys Bioscience, Inc..
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Tethys Bioscience, Inc. Identifier:
First received: May 27, 2013
Last updated: May 30, 2013
Last verified: May 2013
The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice

Resource links provided by NLM:

Further study details as provided by Tethys Bioscience, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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
Serum and plasma

Estimated Enrollment: 560
Study Start Date: June 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
U.S.-based primary care practices

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01869101

Contact: Christine A. Towey, BA 760-520-0394

Sponsors and Collaborators
Tethys Bioscience, Inc.
Study Director: Juan P. Frias, M.D. Tethys Bioscience
Study Chair: David G Marrero, Ph.D. Indiana University School of Medicine
  More Information

Responsible Party: Tethys Bioscience, Inc. Identifier: NCT01869101     History of Changes
Other Study ID Numbers: TET2013-001
Study First Received: May 27, 2013
Last Updated: May 30, 2013

Keywords provided by Tethys Bioscience, Inc.:
Diabetes prevention

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia processed this record on August 23, 2017