Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 560 participants
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
Study Start Date : June 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. fasting glucose [ Time Frame: 6 months ]
  2. Hemoglobin A1C [ Time Frame: 6 months ]
  3. Blood pressure [ Time Frame: 6 months ]
  4. Body weight [ Time Frame: 6 months ]
  5. BMI [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): 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

Responsible Party: Tethys Bioscience, Inc. Identifier: NCT01869101     History of Changes
Other Study ID Numbers: TET2013-001
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: May 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