Status:
COMPLETED
Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid
Spanish Clinical Research Network - SCReN
Conditions:
Obesity Type I and II
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This project is based on the contribution that could offer a technological system for a continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic complications in hi...
Eligibility Criteria
Inclusion
- Preclinical Phase:
- 1\. People over 18 years with or without obesity and with ability for technology management
- Clinical Phase:
- People between 18 and 65 years.
- Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:
- Grade I or II without sleep apnea syndrome and ischemic heart disease
- Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.
- People with ability for technology management
Exclusion
- Preclinical Phase:
- 1\. Serious illness and / or disabling
- Clinical Phase:
- Diabetes defining according to American Diabetes Association (ADA) criteria.
- Subjects with moderate to severe active disease at the time of inclusion in the study protocol
- Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.
- Cardiovascular disease
- Dyslipidemia or hypertension requiring drug treatment.
- Alcohol consumption
- Pregnancy
- Serious illness and / or disabling
Key Trial Info
Start Date :
October 29 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2018
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01919372
Start Date
October 29 2015
End Date
January 25 2018
Last Update
March 7 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025