Weight LossPhase 4NCT06201819
Liraglutide Effectiveness in Preoperative Weight-loss for Bariatric-metabolic Surgery
A Phase 4 study testing Liraglutide injection in people with Weight Loss and Bariatric Surgery Candidate, run by Hospital Civil Juan I. Menchaca at 1 site in Mexico.
Trial summary
Severe obesity is associated with considerable reduction of wellbeing and life expectancy. People living with severe obesity tend to die 8 to 10 years earlier. Preoperative management of patients living with severe obesity can be challenging and proper weight-loss may help obtain better outcomes and less morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Bariatric Surgery Candidate, Obesity, Morbid
- What is being tested?
- Liraglutide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 18 Dec 2022to 1 May 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with BMI greater than 48 kg/m2 in pre-surgical protocol for bariatric surgery of the Bariatric and Metabolic Surgery Unit of the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca
Who cannot join
- Patients under 18 years of age or over 65 years of age.
- Pregnant patients.
- Patients who do not agree to give their consent and take part in the study.
- Patients with allergy to liraglutide, multiple endocrine neoplasia type 2 and medullary thyroid cancer, gallstones.
- Removal:
- Patients who decide to abandon the study.
- Patients who do not follow the instructions or do not adhere to the treatment.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Departamento de Cirugia Bariatrica y Metabolica del Hsopital Civil Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340
About this study
Official title: Liraglutide Effectiveness in Preoperative Weight-loss for Patients With Severe Obesity Undergoing Bariatric-metabolic Surgery.
Severe obesity is associated with considerable reduction of wellbeing and life expectancy. People living with severe obesity tend to die 8 to 10 years earlier. Preoperative management of patients living with severe obesity can be challenging and proper weight-loss may help obtain better outcomes and less morbidity. The effectiveness of GLP-1 analogue Liraglutide in preoperative weight-loss was evaluated in the study.
Read the detailed description
Objective:
Determine liraglutide effectiveness for preoperative weight-loss in patients with severe obesity undergoing bariatric-metabolic surgery.
Methods:
It is a single center, quasi-experimental prospective before-and-after study. All patients were assigned the same pharmacological treatment with liraglutide, initiating dosing with 0.6 mg per day escalating 0.6 mg every week up to 3.0 mg. The treatment dose was delivered once daily via subcutaneous injection for 3 months (12 weeks). Weight-loss and percentage weight-loss was evaluated monthly using bioelectric impedance (BIA) final result at week 12.
- Conditions
- Weight Loss, Bariatric Surgery Candidate, Obesity, Morbid
- Being tested
- Liraglutide injection
- Keywords
- Preoperative weight loss
- Medical subject headings
- Weight Loss, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide injectionDrug
Liraglutide (GLP-1 analog) injection during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with morbid obesity in bariatric surgery preparation protocol | Experimental | All patients with body mass index >48 kg/m2 in preoperative protocol for bariatric surgery using liraglutide for preoperative weight loss Receives: Drug: Liraglutide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative weight changes
Total body weight change during the drug administration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start18 Dec 2022
- Primary completion18 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi-experimental prospective before-and-after study.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil Juan I. Menchaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Daniel Reyes Blandón, Hospital Civil Juan I. Menchaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201819
- Sponsor's protocol ID
- CEI-008-20161212
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide Effectiveness in Preoperative Weight-loss for Patients With Severe Obesity Undergoing Bariatric-metabolic Surgery.
- ClinicalTrials.gov ID
- NCT06201819
- Acronym / sponsor ID
- CEI-008-20161212
- Conditions
- Weight Loss, Bariatric Surgery Candidate, Obesity, Morbid
- Keywords
- Preoperative weight loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital Civil Juan I. MenchacaUniversity, hospital or other
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 11 Jan 2024 (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.
Severe obesity is associated with considerable reduction of wellbeing and life expectancy. People living with severe obesity tend to die 8 to 10 years earlier. Preoperative management of patients living with severe obesity can be challenging and proper weight-loss may help obtain better outcomes and less morbidity. The effectiveness of GLP-1 analogue Liraglutide in preoperative weight-loss was evaluated in the study.
Detailed description
Objective:
Determine liraglutide effectiveness for preoperative weight-loss in patients with severe obesity undergoing bariatric-metabolic surgery.
Methods:
It is a single center, quasi-experimental prospective before-and-after study. All patients were assigned the same pharmacological treatment with liraglutide, initiating dosing with 0.6 mg per day escalating 0.6 mg every week up to 3.0 mg. The treatment dose was delivered once daily via subcutaneous injection for 3 months (12 weeks). Weight-loss and percentage weight-loss was evaluated monthly using bioelectric impedance (BIA) final result at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi-experimental prospective before-and-after study.
| Arm | Type | Receives |
|---|---|---|
| Patients with morbid obesity in bariatric surgery preparation protocol | Experimental | Drug: Liraglutide injectionAll patients with body mass index >48 kg/m2 in preoperative protocol for bariatric surgery using liraglutide for preoperative weight loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with BMI greater than 48 kg/m2 in pre-surgical protocol for bariatric surgery of the Bariatric and Metabolic Surgery Unit of the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca
Key exclusion criteria (7 listed)
- Patients under 18 years of age or over 65 years of age.
- Patients who decide to abandon the study.
- Patients who do not follow the instructions or do not adhere to the treatment.
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 |
|---|---|---|
| Liraglutide injectionLiraglutide (GLP-1 analog) injection during 3 months | Drug | Patients with morbid obesity in bariatric surgery preparation protocol |
Primary outcome
Preoperative weight changes
Time frame: 3 months
Total body weight change during the drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes. Yes
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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 Phase 4 study testing Liraglutide injection in people with Weight Loss and Bariatric Surgery Candidate, run by Hospital Civil Juan I. Menchaca at 1 site in Mexico.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jan 2024. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preoperative weight changes (time frame: 3 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 18 Jan 2024.