Obesity Type I and II Clinical Trial
— PREDIRCAM 2Official title:
Intensificación y monitorización telemática Personalizada de la modificación Del Estilo de Vida en el Tratamiento de la Obesidad y la prevención Del Riesgo cardiometabólico
| Verified date | March 2018 |
| Source | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 high risk population.
The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in
high cardiometabolic risk individuals of a telemedical platform integrating applications for
monitoring and providing recommendations to improve lifestyle habits (diet and physical
activity) in a healthier way.
The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12
month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic
assistance with a technological system and its ability to modify lifestyle habits, reduce
weight and cardiovascular risk associated parameters.
Previously to the clinical implementation, a pilot study for testing the telemedical system
will be made. Efficacy and security variables will be evaluated along the study.
| Status | Completed |
| Enrollment | 183 |
| Est. completion date | January 25, 2018 |
| Est. primary completion date | December 30, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Preclinical Phase: 1. People over 18 years with or without obesity and with ability for technology management Clinical Phase: 1. People between 18 and 65 years. 2. Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2: 1. Grade I or II without sleep apnea syndrome and ischemic heart disease 2. Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study. 3. People with ability for technology management Exclusion Criteria: Preclinical Phase: 1. Serious illness and / or disabling Clinical Phase: 1. Diabetes defining according to American Diabetes Association (ADA) criteria. 2. Subjects with moderate to severe active disease at the time of inclusion in the study protocol 3. Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism. 4. Cardiovascular disease 5. Dyslipidemia or hypertension requiring drug treatment. 6. Alcohol consumption 7. Pregnancy 8. Serious illness and / or disabling |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid, SCReN: Spanish Clinical Research Network ISCIII |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight loss | 1 year | ||
| Secondary | Cardiometabolic risk prevention | We will measure different parameters related to cardiovascular risk, such as adiponectine, tumour necrosis factor, Homeostasis Model Assessment, etc.at the beginning and at the end of the study | 1 year |