Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01869101
• Other study ID #: TET2013-001
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2013
• Last updated: May 30, 2013
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2013
• Source: Tethys Bioscience, Inc.
• Contact: Christine A. Towey, BA
• Phone: 760-520-0394
• Email: ctowey[@]agility-clinical.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tethys Bioscience, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fasting glucose		6 months	No
Other	Hemoglobin A1C		6 months	No
Other	Blood pressure		6 months	No
Other	Body weight		6 months	No
Other	BMI		6 months	No
Primary	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.	6 months	No
Secondary	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.	6 months	No