Telemedicine With Metabolic Syndrome

Last updated: November 2, 2021
Sponsor: Szeged University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

High Cholesterol (Hyperlipidemia)

Metabolic Syndrome

Treatment

N/A

Clinical Study ID

NCT05117580
TMED_METSZI_001
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 years and 75 years
  • Presence of at least three of the following five risk factors (Metabolic Syndrome ATPIII 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

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 voicecalls).
  • For women with childbearing potential, by definition, all women who are able toconceive physiologically use dual contraception
  • Signing an informed consent.
  • The subject communicates well with the investigator and is able to help understand andadhere to the requirements of the study plan.

Study Design

Total Participants: 130
Study Start date:
July 01, 2021
Estimated Completion Date:
February 28, 2022

Study 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.

Connect with a study center

  • University of Szeged

    Szeged, 6720
    Hungary

    Active - Recruiting

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