Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

NCT03849729 | Completed Phase 4 DMC

• 1 other identifier: HJM0367/17-IQF
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obesity; Obesity treatment; Non-alcoholic Fatty Liver; Weight Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Metabolic profile

  Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR.

• Markers of inflammation

  Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR

• 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.

Study Arms (2)

Phentermine

ACTIVE COMPARATOR

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

Drug: Phentermine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Phentermine 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).

Also known as: Terfamex

Phentermine

Placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juárez de México

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Non-alcoholic Fatty Liver Disease; Weight Loss

Interventions

Phentermine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Elizabeth Pérez-Cruz, MD

  Hospital Juárez de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. MD. MSc

Model Details: Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: February 21, 2019
• Study Start: March 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)