Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Morbid Obesity, Bariatric Surgery, Non-alcoholic Fatty Liver, Weight Loss

Intervention / Treatment
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* Drug: Phentermine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phentermine<br>Low-calorie diet + Phentermine Capsules 15 mg po by 6 weeks, one time a day before bariatric surgery. | Drug: Phentermine<br>* 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).<br>* Other names: Terfamex;|
| Placebo Comparator: Placebo<br>Low-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery. | Other: Placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Intrahepatic fat | Intrahepatic fat semi-qualitative asessment: mild(<20%), moderate (20-30%), severe (>30%) | Change from baseline after 6 weeks treatment based on hepatic ultrasound. | 
| Fat tissue | Fat tissue: fat mass in Kilograms and percentage | change from baseline after 6 weeks treatment based on body composition by bioimpedance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic profile | Changes in serum metabolic profile: mg/dL | Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR. | 
| Markers of inflammation | Changes in serum markers of inflammation: pg/mL | Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR | 
| Surgical complications | Prevalence of surgical complications (yes or no): 1) dehiscence of anastomosis, 2) intestinal obstruction, 3) intestinal stenosis | Surgical complications during hospitalization and up to 30 days after surgery 1) dehiscence of anastomosis, 2) intestinal obstruction, 3) intestinal stenosis | 
| Adverse events associated with phentermine | Determine the frequency and severity of adverse events | Adverse events during and the end of 6-8 weeks of phentermine (blood pressure, cardiac frequency, headache, gastrointestinal symptoms, euphoria, anxiety and insomnia) associated with phentermine. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Obesity treatment, Non-alcoholic Fatty Liver, Weight Loss