Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Phase 4

Completed

• Conditions: Obesity; Morbid Obesity; Bariatric Surgery; Weight Loss; Non-alcoholic Fatty Liver
• Interventions: Other: Placebo; Drug: Phentermine

• Registration Number: NCT03849729
• Lead Sponsor: Hospital Juarez de Mexico

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Low-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery.
Phentermine	Phentermine	Low-calorie diet + Phentermine Capsules 15 mg po by 6 weeks, one time a day before bariatric surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Hospital Juárez de México; 🇲🇽 Ciudad de México, Cdmx, Mexico