Clinical trial NCT03921853: Resistance Training in Patients With Morbid Obesity
Official title: Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Obesity
Physical Activity
Metabolic Syndrome
Risk Factor, Cardiovascular
Lead sponsor: Universidad de Los Lagos
Sponsor class: OTHER
Collaborators: name: Universidad de La Frontera
First posted: 2019-04-19
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.
Primary purpose: PREVENTION

Brief summary: The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.

Detailed description: The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.

Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Older than 18 and younger and ≤65 years of age.
* With risk factors to Metabolic syndrome
* With obesity and morbid obesity condition
* Medical authorization by a physician.

Exclusion Criteria:

* Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
* Exercise-related dyspnoea or respiratory alterations.
* Chronic heart disease with any worsening in the last month.
* Adherence rate of less than 80% of the total interventions.

Primary outcomes:
measure: Fasting glucose
timeFrame: Change from Baseline Fasting glucose at 20-weeks of Resistant Training
measure: High density lipoprotein
timeFrame: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
measure: Systolic blood pressure and diastolic blood pressure
timeFrame: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
measure: Waist circumference
timeFrame: Change from Baseline Waist circumference at 20-weeks of Resistant Training
measure: Triglycerides
timeFrame: Change from Baseline Triglycerides at 20-weeks of Resistant Training
Secondary outcomes:
measure: Body mass index
timeFrame: Change from Baseline Body mass index at 20-weeks of Resistant Training
measure: Body mass
timeFrame: Change from Baseline Body mass at 20-weeks of Resistant Training
measure: Total cholesterol
timeFrame: Change from Baseline Total cholesterol at 20-weeks of Resistant Training
measure: Low density lipoprotein
timeFrame: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
measure: Six minutes walking test
timeFrame: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
measure: One maximum repetition of biceps curl
timeFrame: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
measure: Handgrip muscle strength
timeFrame: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
Other outcomes:
Locations:
city: Osorno
country: Chile
facility: Cristian ALvarez
state: Llanquihue
Study officials:
affiliation: Universidad de Los Lagos
name: Cristian ALvarez, PhD
role: STUDY_DIRECTOR
References:
citation: Delgado-Floody P, Alvarez C, Lusa Cadore E, Flores-Opazo M, Caamano-Navarrete F, Izquierdo M. Preventing metabolic syndrome in morbid obesity with resistance training: Reporting interindividual variability. Nutr Metab Cardiovasc Dis. 2019 Dec;29(12):1368-1381. doi: 10.1016/j.numecd.2019.07.002. Epub 2019 Jul 12.