METSZI: Telemedicine With Metabolic Syndrome

Sponsor

Szeged University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05117580

Collaborator

(none)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Life Style	Device: telemedicine lifestyle guidance	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active group The active group get telemedicine devices, and lifestyle interventions.	Device: telemedicine lifestyle guidance Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.
No Intervention: Comparator Group The comparator group get the evidence based treatment.

Arm

Intervention/Treatment

Experimental: Active group

The active group get telemedicine devices, and lifestyle interventions.

Device: telemedicine lifestyle guidance

Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.

No Intervention: Comparator Group

The comparator group get the evidence based treatment.

Outcome Measures

Primary Outcome Measures

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

Number of participants with treatment-related adverse events as assessed by CTCAE v4. [3 months]
The safety of the device system
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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):

waist width above 102 cm in men and 88 cm in women
treated diabetes or blood sugar above 5.6 mmol / l
treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg
fibrate treatment or triglyceride levels above 1.7 mmol / l
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Szeged	Szeged		Hungary	6720

Sponsors and Collaborators

Szeged University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Szeged University

ClinicalTrials.gov Identifier:

NCT05117580

Other Study ID Numbers:

TMED_METSZI_001

First Posted:

Nov 11, 2021

Last Update Posted:

Nov 11, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Szeged University

Telemedicine

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Nov 11, 2021