Clinical trial NCT03849729: Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery
Official title: Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Morbid Obesity
Bariatric Surgery
Non-alcoholic Fatty Liver
Weight Loss
Keywords: Obesity
Obesity treatment
Non-alcoholic Fatty Liver
Weight Loss
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2019-02-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Intrahepatic fat
timeFrame: Change from baseline after 6 weeks treatment based on hepatic ultrasound.
measure: Fat tissue
timeFrame: change from baseline after 6 weeks treatment based on body composition by bioimpedance
Secondary outcomes:
measure: Metabolic profile
timeFrame: Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR.
measure: Markers of inflammation
timeFrame: Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR
measure: Surgical complications
timeFrame: Surgical complications during hospitalization and up to 30 days after surgery 1) dehiscence of anastomosis, 2) intestinal obstruction, 3) intestinal stenosis
measure: Adverse events associated with phentermine
timeFrame: 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.
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Hospital Juárez de México
state: Cdmx
Study officials:
affiliation: Hospital Juárez de México
name: Elizabeth Pérez-Cruz, MD
role: PRINCIPAL_INVESTIGATOR
References: