Metabolic Syndrome Clinical Trial
— METSZIOfficial title:
Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age between 18 years and 75 years - Presence of at least three of the following five risk factors (Metabolic Syndrome ATP III Criteria): 1. waist width above 102 cm in men and 88 cm in women 2. treated diabetes or blood sugar above 5.6 mmol / l 3. treated hypertension or spontaneous blood pressure = 130/85 mmHg 4. fibrate treatment or triglyceride levels above 1.7 mmol / l 5. blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women Exclusion Criteria: - Low level of physical activity (less than 30 minutes a day) - IT proficiency at least for basic use of mobile phones (answering / making voice calls). - For women with childbearing potential, by definition, all women who are able to conceive physiologically use dual contraception - Signing an informed consent. - The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan. |
Country | Name | City | State |
---|---|---|---|
Hungary | University of Szeged | Szeged |
Lead Sponsor | Collaborator |
---|---|
Szeged University |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of abdominal circumference | To investigate the effect of telemedicine-assisted lifestyle intervention on anthropometric parameters, with particular reference to the reduction of abdominal circumference in patients with metabolic syndrome. | 3 months | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4. | The safety of the device system | 3 months | |
Secondary | Impact of the system to the cardiovascular risk | In patients with metabolic syndrome, high cardiovascular risk, the impact of complex lifestyle interventions initiated in different environments and then telemedicine, including lifestyle and physical activity, on the known cardiovascular risk factors and functional indicators | 3 months |
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