Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Number of participants with Intrahepatic fat
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Phentermine
Low-calorie diet + Phentermine Capsules 15 mg po by 6 weeks, one time a day before bariatric surgery.
干预措施: Phentermine (Drug)
Placebo
Low-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with Intrahepatic fat
时间窗: 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
时间窗: change from baseline after 6 weeks treatment based on body composition by bioimpedance
Fat tissue: fat mass in Kilograms and percentage
次要结局
- Metabolic profile(Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR.)
- Surgical complications(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(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.)
- Markers of inflammation(Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR)
研究者
ELIZABETH PEREZ CRUZ
Principal Investigator. MD. MSc
Hospital Juarez de Mexico