Telemedicine With Metabolic Syndrome (METSZI)

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

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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Life Style
• Intervention / Treatment: Device: telemedicine lifestyle guidance

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: István Kósa, MD, Ph.D.; Phone Number: +36 70 320 1192; Email: office.prevmedicina@med.u-szeged.hu

Study Locations

• Hungary
  • Szeged, Hungary, 6720
    • Recruiting
    • University of Szeged
    • Contact: István Kósa, MD, Ph.D.; Phone Number: +36 70 320 1192; Email: office.prevmedicina@med.u-szeged.hu
    • Principal Investigator: istván Kósa, MD Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.	The safety of the device system	3 months
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	3 months

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: TMED_METSZI_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No