Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Morbid Obesity; Bariatric Surgery; Non-alcoholic Fatty Liver
• Intervention / Treatment: Drug: Phentermine; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Cdmx
    • Ciudad de México, Cdmx, Mexico, 07760
      • Hospital Juarez de Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hospital Juarez de Mexico
• Investigators: Principal Investigator: Elizabeth Pérez-Cruz, MD, Hospital Juarez de Mexico

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Weight Loss; Obesity treatment; Non-alcoholic Fatty Liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Fatty Liver; Weight Loss; Non-alcoholic Fatty Liver Disease; Obesity, Morbid; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Phentermine
• Other Study ID Numbers: HJM0367/17-IQF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No