Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Tethys Bioscience, Inc.
Sponsor:
Information provided by (Responsible Party):
Tethys Bioscience, Inc.
ClinicalTrials.gov Identifier:
NCT01869101
First received: May 27, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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


Condition
Prediabetes

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Hemoglobin A1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

U.S.-based primary care practices

Criteria

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 ClinicalTrials.gov identifier: NCT01869101

Contacts
Contact: Christine A. Towey, BA 760-520-0394 ctowey@agility-clinical.com

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

No publications provided

Responsible Party: Tethys Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT01869101     History of Changes
Other Study ID Numbers: TET2013-001
Study First Received: May 27, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tethys Bioscience, Inc.:
Prediabetes
Diabetes prevention

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014