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The effectiveness of SHP Program for the Improvement of Cardiovascular Risk Factors in Metabolic Syndrome Patients : A Multicenter, Randomized, Controlled Trial

The effectiveness of SHP Program for the Improvement of Cardiovascular Risk Factors in Metabolic Syndrome Patients : A Multicenter, Randomized, Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004582
Enrollment
300
Registered
2019-12-24
Start date
2020-01-02
Completion date
Unknown
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : •We will divide the subjects enrolled by the inclusion and exclusion criteria into three groups. •We will randomize subjects in the same proportions to Intervention Group 1 (Basic Healthcare

Sponsors

Hotel Shilla
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age: over 20 years old 2) body mass index (BMI) = 25 kg / m2 3) Metabolic Syndrome         * Those who meet 3 or more of the following 5 elements         (1) abdominal obesity: waist = 90 cm (male), 85 cm (female)         (2) blood pressure = 130/85 mmHg         (3) fasting blood sugar = 100 mg / dL         (4) triglyceride = 150 mg / dL or Patients taking fibrate medications         (5) high-density lipoprotein cholesterol (HDL-C) <40 mg /dL (male), 50 mg /dL (Female) 4) Patients who can understand, read, and write the purpose of clinical research 5) Patients who can use the smartphone application used for clinical research 6) Patients who voluntarily participate and sign a consent form

Exclusion criteria

Exclusion criteria: 1) Participants in a diet or weight loss healthcare program within 12 weeks prior to the screening visit 2) Patients who are currently in hospital or are expected to need hospitalization within the clinical study period 3) Patients diagnosed with myocardial infarction or stroke within the last year 4) Patients with end stage renal failure who need renal replacement therapy Serum creatine levels are more than 1.5 times the upper limit of normal 5) Pregnant women 6) Liver Failure (Severe Liver Disorder Patients)     Serum liver enzyme (AST or ALT) is more than five times the upper limit of normal 7) Uncontrolled chronic lung disease 8) Phentermin, orlistat ? ????? ?? ???? ??? ?? 9) Patients taking drugs that may affect their weight (eg psychiatric drugs) 10) Patients who have a medical condition that is likely to affect clinical research results, such as clinically significant neurological disease, gastrointestinal disease, or malignant tumor, or are inappropriate for participation in clinical research, as judged by the investigator. 11) Participants in other clinical studies (excluding observational studies) within 12 weeks before the screening visit 12) Type I and Type II Diabetics requiring Insulin Treatment 13) Participants who have had a weight change of more than 10% of their weight in the last year

Design outcomes

Primary

MeasureTime frame
Changes in body weight, body mass index, and metabolic syndrome prevalence

Secondary

MeasureTime frame
Test results and lifestyle changes related to obesity and metabolic syndrome, including blood pressure, serum lipids, liver function, uric acid, blood sugar, and insulin resistance

Countries

Korea, Republic of

Contacts

Public ContactJihyun Nam

Kangbuk Samsung Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026