CompletedPhase 4

Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Mexico92 participantsStarted 2018-03-01

Plain-language summary

Surgical management of Morbid Obesity is increasingly frequent. A low-calorie diet is recommended with the main goal of reducing intrahepatic fat infiltration, fat tissue and making easier the surgery. Information the use pharmacological interventions during the preoperative period in this population are rare.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women and men * \>18 years and \<55 years old. * Diagnosis of obesity grade II with comorbidities * Diagnosis of obesity grade III with or without comorbidities * Approved to bariatric surgery by an interdisciplinary committee * Having signed the Informed consent form Exclusion Criteria: * Use of addictive substances * Inability or lack of understanding to achieve lifestyle and behaviour changes * Mental disease * Severe Pulmonary disease * Giant Hiatal hernia, gastric or duodenal ulcer * Unstable coronary artery disease * Portal hypertension or esophageal varices * Surgical or anesthetic high risk

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Intrahepatic fat

Timeframe: Change from baseline after 6 weeks treatment based on hepatic ultrasound.

Fat tissue

Timeframe: change from baseline after 6 weeks treatment based on body composition by bioimpedance

Trial details

NCT IDNCT03849729

SponsorHospital Juarez de Mexico

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-04-01

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