Telemedicine With Metabolic Syndrome

Not Applicable

• Conditions: Metabolic Syndrome; Life Style
• Interventions: Device: telemedicine lifestyle guidance

• Registration Number: NCT05117580
• Lead Sponsor: Szeged University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	telemedicine lifestyle guidance	The active group get telemedicine devices, and lifestyle interventions.

Primary Outcome Measures

Name	Time	Method
Change of abdominal circumference	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Impact of the system to the cardiovascular risk	3 months	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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.	3 months	The safety of the device system

Trial Locations

Locations (1)

University of Szeged; 🇭🇺 Szeged, Hungary