Intensive versus standard care and education for cholesterol management in people with hypertension and diabetes
Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients
NA · Saint Vincent's Hospital, Korea · NCT07045623
This project will test whether a structured, intensive dyslipidemia management and education program helps adults with hypertension and diabetes improve their blood lipid levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Saint Vincent's Hospital, Korea (other) |
| Locations | 1 site (Gyeonggi-do, Suwon-si) |
| Trial ID | NCT07045623 on ClinicalTrials.gov |
What this trial studies
Adults aged 30–80 who are registered in the Hanam City Hypertension and Diabetes Program will be assigned to receive either a centralized intensive dyslipidemia management and education program or usual/standard care. The intensive arm uses structured education, lifestyle counseling, and coordinated management to reinforce medication adherence and lifestyle changes. Primary outcomes focus on changes in blood lipid profiles, while secondary outcomes include quality of life, health behaviors, and treatment adherence. Results will inform whether a standardized intensive program is practical and effective in a primary-care affiliated education center.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30–80 who are registered with the Hanam City Hypertension and Diabetes Program, have hypertension and diabetes, and can give written informed consent.
Not a fit: Patients with advanced kidney disease (eGFR <30), severe liver disease or cirrhosis, recent acute coronary syndrome within 6 months, pregnant or breastfeeding women, or those with psychiatric disorders interfering with participation are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could help patients achieve better cholesterol control, improve adherence and lifestyle habits, and lower long-term cardiovascular risk.
How similar studies have performed: Previous research has shown that intensive lipid management and education can improve lipid profiles and reduce cardiovascular events, though standardized programs in primary-care settings are less well validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients registered in the Hanam City Hypertension and Diabetes Program * Adults aged 30 to 80 years * Individuals who have provided written informed consent to participate in the study Exclusion Criteria: * Chronic kidney disease stage 4 or higher (eGFR \<30 mL/min/1.73m²) * Patients with liver cirrhosis or severe liver disease * Patients with a history of acute coronary syndrome within the past 6 months * Pregnant or breastfeeding women • Individuals with psychiatric disorders that may affect study participation
Where this trial is running
Gyeonggi-do, Suwon-si
- Catholic University of Korea, ST. Vincent's Hospital. — Gyeonggi-do, Suwon-si, South Korea (RECRUITING)
Study contacts
- Study coordinator: Sung-Ho Her
- Email: hhhsungho@naver.com
- Phone: +82312598397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Diabetes Mellitus, Dyslipidemia, Primary Prevention, Primary prevention, Chronic disease