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Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849729
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
ELIZABETH PEREZ CRUZ, 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.

Condition or disease Intervention/treatment Phase
Obesity Morbid Obesity Bariatric Surgery Non-alcoholic Fatty Liver Weight Loss Drug: Phentermine Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double-blinded
Primary Purpose: Treatment
Official Title: Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020


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 Name: 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).




Primary Outcome Measures :
  1. 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%)

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849729


Contacts
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Contact: Elizabeth Pérez-Cruz, MD 5557477569 ext 7497 pece_liz@yahoo.com.mx
Contact: Pérez-Cruz, MD

Locations
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Mexico
Hospital Juárez de México Recruiting
Ciudad de México, Cdmx, Mexico, 07760
Contact: Elizabeth PEREZ-CRUZ, MD    5557477560 ext 7497    pece_liz@yahoo.com.mx   
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
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Principal Investigator: Elizabeth Pérez-Cruz, MD Hospital Juárez de México

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Responsible Party: ELIZABETH PEREZ CRUZ, Principal Investigator. MD. MSc, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT03849729    
Other Study ID Numbers: HJM0367/17-IQF
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ELIZABETH PEREZ CRUZ, Hospital Juarez de Mexico:
Obesity
Obesity treatment
Non-alcoholic Fatty Liver
Weight Loss
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Obesity
Obesity, Morbid
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Liver Diseases
Digestive System Diseases
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action