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Telemedicine With Metabolic Syndrome (METSZI)

U

University of Szeged (SZTE)

Status

Unknown

Conditions

Life Style
Metabolic Syndrome

Treatments

Device: telemedicine lifestyle guidance

Study type

Interventional

Funder types

Other

Identifiers

NCT05117580
TMED_METSZI_001

Details and patient eligibility

About

Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.

Full description

The patients are using mobile phone-based nutrition diary with heart rate monitoring watch (including activity meter) connected to a mobile phone with bluetooth technology worn on a wrist. These devices, and the weight scale, blood pressure monitor are connected with bluetooth to an IT system, that transmits and displays data from these devices. the patients are using the devices during 3 months, and get instructions about lifestyle.

Enrollment

130 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

130 participants in 2 patient groups

Active group
Experimental group
Description:
The active group get telemedicine devices, and lifestyle interventions.
Treatment:
Device: telemedicine lifestyle guidance
Comparator Group
No Intervention group
Description:
The comparator group get the evidence based treatment.

Trial contacts and locations

1

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Central trial contact

István Kósa, MD, Ph.D.

Data sourced from clinicaltrials.gov

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