Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

May 30, 2013 updated by: Tethys Bioscience, Inc.

A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

U.S.-based primary care practices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 6 months
6 months
BMI
Time Frame: 6 months
6 months
Hemoglobin A1C
Time Frame: 6 months
6 months
Body weight
Time Frame: 6 months
6 months
fasting glucose
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TET2013-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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