Bariatric Surgery, Morbid Obesity, Non-alcoholic Fatty Liver, Obesity, Weight Loss
Conditions
Keywords
Obesity, Obesity treatment, Non-alcoholic Fatty Liver, Weight Loss
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. 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.
Interventions
DRUGPhentermine
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).
OTHERPlacebo
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).
Sponsors
Hospital Juarez de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blinded
Intervention model description
Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Intrahepatic fat | Change from baseline after 6 weeks treatment based on hepatic ultrasound. | Intrahepatic fat semi-qualitative asessment: mild(\<20%), moderate (20-30%), severe (\>30%) |
| Fat tissue | change from baseline after 6 weeks treatment based on body composition by bioimpedance | Fat tissue: fat mass in Kilograms and percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic profile | Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR. | Changes in serum metabolic profile: mg/dL |
| Markers of inflammation | Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR | Changes in serum markers of inflammation: pg/mL |
| Surgical complications | Surgical complications during hospitalization and up to 30 days after surgery 1) dehiscence of anastomosis, 2) intestinal obstruction, 3) intestinal stenosis | Prevalence of surgical complications (yes or no): 1) dehiscence of anastomosis, 2) intestinal obstruction, 3) intestinal stenosis |
| Adverse events associated with phentermine | 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. | Determine the frequency and severity of adverse events |
Countries
Mexico
Outcome results
None listed