Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT01416766
Eligibility Criteria:
Inclusion Criteria:
* diagnoses of both diabetes mellitus (MODIFICATION 2/13: prediabetes) and hypertension
* uncontrolled hypertension (mean of up to most recent 3 clinic BPs in previous 6 months with SBP\>=145 and/or DBP\>=85) AND mean of 3 readings taken at intake visit meeting same criterion
Exclusion Criteria:
* end-stage renal disease
* management of blood pressure by provider other than primary care provider (PCP)
* pregnancy/gestational diabetes
* terminal illness
* diagnosed or probable (based on screen) dementia
* active psychosis
* moderate-severe mental retardation
* indication by PCP that patient would be inappropriate for study
* planning to leave Reliant Medical Group (formerly Fallon Clinic) during the coming year
MODIFICATIONS: due to a smaller pool of eligible participants and lower enrollment than anticipated, eligibility for the study has been expanded as of February 2013 to include persons with "prediabetes," defined by either a coded diagnosis of abnormal glucose (International Classification of Diseases \[ICD\] 9-CM codes 790.2x) or a hemoglobin A1c laboratory value from 6.0%-6.4%. For this group, the DBP eligibility criterion will be a mean, as defined above, of \>=95, as target BP for this group is 140/90, not 140/80.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01416766
Study Brief:
Protocol Section:
NCT01416766