Clinical trial NCT04583683: Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
Official title: Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Morbid
Obesity
Diet, Healthy
Bariatric Surgery Candidate
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 218
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

Detailed description: Obesity is a leading public health issued associated with poor quality of life, morbidity and an increased mortality rate. Although metabolic surgery results in a greater weight loss when compared to non-surgical approaches, a low calorie diet associated with intensive maintenance session may be a valid alternative for weight loss. Since lifestyle interventions are safer and potentially more cost effective than metabolic surgery, this trial will test whether an intensive lifestyle intervention is as effective as metabolic surgery to induce weight loss and its maintenance.

A total of 218 participants will be randomly assigned to metabolic surgery (109) or intensive lifestyle intervention (109).

Clinical outcomes will be assessed at 25% reduction in Body Mass Index (BMI), at 12 months and 24 months.

Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 69 years
* Body Mass Index ≥35 kg/m2 and at least one or more obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease
* Body Mass Index ≥40 kg/m2

Exclusion Criteria:

* Pregnancy
* Active cancer
* End stage renal failure
* End stage liver failure
* Being unable to understand and sign informed consent

Primary outcomes:
measure: Time to achieve a 25% reduction in Body Mass Index
timeFrame: 1-12 months
Secondary outcomes:
measure: Percentage of participants who achieve 25% reduction in Body Mass Index
timeFrame: 1-12 months
measure: Time to achieve 25% reduction in Body Mass Index
timeFrame: 1-24months
measure: Change in body composition (lean mass-all tissues in the body except bone and fat-fat mass, bone density and visceral fat) using dual energy X-ray absorptiometry (DXA), from baseline, at 25% weight loss, at 12 months follow up and at 24 months follow up
timeFrame: 1-24months
measure: Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)
timeFrame: 1-24months
measure: Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up
timeFrame: 1-24months
measure: Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up
timeFrame: 1-24months
measure: Change in blood pressure, from baseline, at 12 and 24 months follow up
timeFrame: 1-24months
measure: Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up
timeFrame: 1-24months
measure: Change in triglycerides from baseline, at 12 and 24 months follow up
timeFrame: 1-24months
measure: Percentage of participants who maintain weight loss at 24 months follow up
timeFrame: 1-24months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University School of Medicine
Study officials:
References: