Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05117580
Other study ID # TMED_METSZI_001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date February 28, 2022

Study information

Verified date October 2021
Source Szeged University
Contact István Kósa, MD, Ph.D.
Phone +36 70 320 1192
Email office.prevmedicina@med.u-szeged.hu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
telemedicine lifestyle guidance
Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.

Locations

Country Name City State
Hungary University of Szeged Szeged

Sponsors (1)

Lead Sponsor Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants with treatment-related adverse events as assessed by CTCAE v4. The safety of the device system 3 months
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A