PrediabetesNCT01869101
Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes
An observational study of Prediabetes, run by Tethys Bioscience, Inc..
Trial summary
The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: U.S.-based primary care practices
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Diabetes prevention
- Medical subject headings
- Prediabetic State
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes prevention treatment decisions by physician
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.
Measured: 6 months
Secondary outcomes (1)
Subject initiation and persistence with diabetes prevention interventions
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tethys Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan P. Frias, M.D., Study director, Tethys BioscienceDavid G Marrero, Ph.D., Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869101
- Sponsor's protocol ID
- TET2013-001
- Status last verified
- May 2013
- First submitted
- 27 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice
- ClinicalTrials.gov ID
- NCT01869101
- Acronym / sponsor ID
- TET2013-001
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Diabetes prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Tethys Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- U.S.-based primary care practices
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Subject initiation and persistence with diabetes prevention interventions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P. Frias, M.D. study director
Tethys Bioscience
David G Marrero, Ph.D. study chair
Indiana University
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes, run by Tethys Bioscience, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine A. Towey, BA (760-520-0394, ctowey@agility-clinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes prevention treatment decisions by physician (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.