Obesity Clinical Trial
Official title:
Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery
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.
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.
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