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 range18 Years – 55 Years

SexALL

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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

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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