Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population

Cardiovascular Diseases Clinical Trial

— PANDEMONIO  

Official title:

Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03701425
• Other study ID #: 083.2018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2018
• Source: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The diseases derived from Metabolic Syndrome caused 75% of the total deaths. It is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. Several institutions consider prevention as one of the main priorities in public health.

Patients with Metabolic Syndrome, undergoing Mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise.

OBJECTIVE: To evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a Mediterranean diet program and / or controlled physical activity.

Design: Experimental, longitudinal design, controlled clinical trial, randomized. Population with Metabolic Syndrome in which the effect of Mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 31
• Est. completion date: December 1, 2024
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of metabolic syndrome.

• Patients diagnosed with overweight.

• Patients diagnosed with obesity.

• Patients with a diagnosis of systemic arterial hypertension.

• Patients diagnosed with type 2 diabetes mellitus.

• Patients with dyslipidemia.

Exclusion Criteria:

• Recent myocardial infarction

• Pregnancy

• Lactation

• In pharmacological treatment for weight loss.

• Cancer.

• Chronic kidney disease

• Liver failure

• Heart failure.

• Chronic obstructive pulmonary disease

• Depression

• Malabsorption syndrome

• Chronic diarrhea

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Mediterranean Diet
• Metabolic Syndrome x

Intervention

Dietary Supplement:
• Mediterranean diet and exercise plan
Mediterranean diet: Diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30%

Locations

Country	Name	City	State
Mexico	National Medical Center "20 de Noviembre", ISSSTE	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the profiles of body composition in the different groups.	Measure the basal profiles of body composition (weight in kilograms and height in meters, body mass index in kg/m^2, bio impedance will be done by bioimpedance multifrequency, 8 points) in the different groups	3 months
Primary	Measure the profiles of pro inflammatory biomarkers.	Determine the basal pro-inflammatory biomarkers (interleukins 1 beta in picograms per liter , interleukin 2 in picograms per liter , interleukins 10 in picograms per liter ) in the 4 different groups.	3 months
Primary	Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome.	To compare the profiles of body composition and proinflammatory biomarkers after a program of physical activity and feeding plan, in the different groups of patients with metabolic syndrome after the follow-up and classify by groups, responds or not responds for analysis	3 months