Obesity, MorbidARGOSNCT04583683
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
A study testing Very low calorie diet with Fortimel (Nutricia) supplementation and Metabolic Surgery in people with Obesity, Morbid and Obesity, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Obesity, Morbid, Obesity, Diet, Healthy
- What is being tested?
- Very low calorie diet with Fortimel (Nutricia) supplementation and Metabolic Surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Active cancer
- End stage renal failure
- End stage liver failure
- Being unable to understand and sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity, Morbid, Obesity, Diet, Healthy, Bariatric Surgery Candidate
- Being tested
- Very low calorie diet with Fortimel (Nutricia) supplementation, Metabolic Surgery
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low calorie diet with Fortimel (Nutricia) supplementationBehavioural
Patients will undergo a very low calorie diet
Metabolic SurgeryProcedure or surgery
Patients will undergo metabolic surgery
| Study group | Role | What they receive |
|---|---|---|
| Intensive lifestyle modification: Very low calorie diet | Active comparator | Patients will undergo a very low calorie diet Receives: Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementation |
| Metabolic Surgery | Active comparator | Patients will undergo metabolic surgery Receives: Procedure: Metabolic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve a 25% reduction in Body Mass Index
Measured: 1-12 months
Secondary outcomes (10)
Percentage of participants who achieve 25% reduction in Body Mass Index
Measured: 1-12 months
Time to achieve 25% reduction in Body Mass Index
Measured: 1-24months
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
Measured: 1-24months
Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)
Measured: 1-24months
Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up
Measured: 1-24months
Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up
Measured: 1-24months
Change in blood pressure, from baseline, at 12 and 24 months follow up
Measured: 1-24months
Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up
Measured: 1-24months
Change in triglycerides from baseline, at 12 and 24 months follow up
Measured: 1-24months
Percentage of participants who maintain weight loss at 24 months follow up
Measured: 1-24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start30 Sep 2020
- Primary completion28 Dec 2020
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geltrude Mingrone, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583683
- Sponsor's protocol ID
- 20203009
- Acronym
- ARGOS
- Status last verified
- May 2021
- First submitted
- 30 Sep 2020
- Last updated
- 25 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04583683
- Acronym / sponsor ID
- ARGOS / 20203009
- Conditions
- Obesity, Morbid, Obesity, Diet, Healthy, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive lifestyle modification: Very low calorie diet | Active comparator | Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementationPatients will undergo a very low calorie diet |
| Metabolic Surgery | Active comparator | Procedure: Metabolic SurgeryPatients will undergo metabolic surgery |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Active cancer
- End stage renal failure
- End stage liver failure
- Being unable to understand and sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low calorie diet with Fortimel (Nutricia) supplementationPatients will undergo a very low calorie diet | Behavioural | Intensive lifestyle modification: Very low calorie diet |
| Metabolic SurgeryPatients will undergo metabolic surgery | Procedure or surgery | Metabolic Surgery |
Primary outcome
Time to achieve a 25% reduction in Body Mass Index
Time frame: 1-12 months
10 secondary outcomes
Percentage of participants who achieve 25% reduction in Body Mass Index
Time frame: 1-12 months
Time to achieve 25% reduction in Body Mass Index
Time frame: 1-24months
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
Time frame: 1-24months
Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)
Time frame: 1-24months
Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in blood pressure, from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in triglycerides from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Percentage of participants who maintain weight loss at 24 months follow up
Time frame: 1-24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low calorie diet with Fortimel (Nutricia) supplementation and Metabolic Surgery in people with Obesity, Morbid and Obesity, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve a 25% reduction in Body Mass Index (time frame: 1-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.