NCT03849729

Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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). Screening will be made to select eligible participants before intervention. Participants were randomly assigned to one of two groups (low-calorie diet + phentermine 15 mg or low-calorie diet + placebo) for therapies during 6 weeks. Anthropometric measurements (weight, body composition, body mass index and waist-hip index), serum metabolic profile (glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR) markers of inflammation (IL-1, IL-6 and PCR) and hepatic ultrasound will be measured 2 times for each participant. Surgical complications (anastomosis filtration, intestinal obstruction or stenosis, need to perform open surgery and mortality) will be evaluated. Adverse events associated with phentermine (blood pressure, cardiac frequency, headache, gastrointestinal symptoms, euphoria, anxiety and insomnia) will be collected.

Conditions

• Obesity
• Morbid Obesity
• Bariatric Surgery
• Non-alcoholic Fatty Liver
• Weight Loss

Interventions

Type	Name	Description
DRUG	Phentermine	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).
OTHER	Placebo	his 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).

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-02-21
• Last updated: 2020-07-29

Locations

1 site across 1 country: Mexico