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Completed

NCT Number: NCT03849729

Effectiveness and Tolerability of Phentermine 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.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Body Weight Changes Digestive System Diseases Fatty Liver Liver Diseases Morbid Obesity Non-alcoholic Fatty Liver Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Juárez de México

Mexico City, 07760, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Terfamex

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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