Telemedicine With Metabolic Syndrome
METSZI
Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedNovember 11, 2021
October 1, 2021
8 months
October 5, 2021
November 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.
3 months
Impact of the system to the cardiovascular risk
3 months
Study Arms (2)
Active group
EXPERIMENTALThe active group get telemedicine devices, and lifestyle interventions.
Comparator Group
NO INTERVENTIONThe comparator group get the evidence based treatment.
Interventions
Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Szeged
Szeged, 6720, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
November 11, 2021
Study Start
July 1, 2021
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
November 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share