Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

NCT ID: NCT03849729

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-04-01

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.

Conditions

Obesity; Morbid Obesity; Bariatric Surgery; Non-alcoholic Fatty Liver; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Phentermine

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

Group Type: ACTIVE_COMPARATOR

Phentermine

Intervention Type: DRUG

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).

Placebo

Low-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: OTHER

Other Intervention Names

Terfamex

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

ELIZABETH PEREZ CRUZ

Principal Investigator. MD. MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Pérez-Cruz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juárez de México

Locations

Hospital Juárez de México

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HJM0367/17-IQF

Identifier Type: -

Identifier Source: org_study_id