Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

July 27, 2020 updated by: ELIZABETH PEREZ CRUZ, Hospital Juarez de Mexico

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Intrahepatic fat
Time Frame: Change from baseline after 6 weeks treatment based on hepatic ultrasound.
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
Time Frame: change from baseline after 6 weeks treatment based on body composition by bioimpedance
Fat tissue: fat mass in Kilograms and percentage
change from baseline after 6 weeks treatment based on body composition by bioimpedance

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic profile
Time Frame: 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
Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR.
Markers of inflammation
Time Frame: Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR
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
Time Frame: 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
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Juarez de Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Pérez-Cruz, MD, Hospital Juarez de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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