search
Back to results

Telemedicine With Metabolic Syndrome (METSZI)

Primary Purpose

Metabolic Syndrome, Life Style

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
telemedicine lifestyle guidance
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome focused on measuring Telemedicine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of SzegedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active group

Comparator Group

Arm Description

The active group get telemedicine devices, and lifestyle interventions.

The comparator group get the evidence based treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2021
Last Updated
November 2, 2021
Sponsor
Szeged University
search

1. Study Identification

Unique Protocol Identification Number
NCT05117580
Brief Title
Telemedicine With Metabolic Syndrome
Acronym
METSZI
Official Title
Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szeged University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Life Style
Keywords
Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Experimental
Arm Description
The active group get telemedicine devices, and lifestyle interventions.
Arm Title
Comparator Group
Arm Type
No Intervention
Arm Description
The comparator group get the evidence based treatment.
Intervention Type
Device
Intervention Name(s)
telemedicine lifestyle guidance
Intervention Description
Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.
Primary Outcome Measure Information:
Title
Change of abdominal circumference
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.
Description
The safety of the device system
Time Frame
3 months
Title
Impact of the system to the cardiovascular risk
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
István Kósa, MD, Ph.D.
Phone
+36 70 320 1192
Email
office.prevmedicina@med.u-szeged.hu
Facility Information:
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
István Kósa, MD, Ph.D.
Phone
+36 70 320 1192
Email
office.prevmedicina@med.u-szeged.hu
First Name & Middle Initial & Last Name & Degree
istván Kósa, MD Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telemedicine With Metabolic Syndrome

We'll reach out to this number within 24 hrs