Status:

COMPLETED

Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Lead Sponsor:

Hospital Juarez de Mexico

Conditions:

Obesity

Morbid Obesity

Eligibility:

All Genders

18-55 years

Phase:

PHASE4

Brief 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...

Detailed Description

This is a randomized, control trial to investigate the effect and safety of Phentermine in patients with obesity who need a bariatric surgery (BMI \>35 kg/m2 with comorbidities or BMI \> 40 kg/m2). S...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2020

Estimated Enrollment :

92 Patients enrolled

Trial Details

Trial ID

NCT03849729

Start Date

March 1 2018

End Date

April 1 2020

Last Update

July 29 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hospital Juárez de México

Mexico City, Mexico City, Mexico, 07760