Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849729
• Other study ID #: HJM0367/17-IQF
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: Hospital Juarez de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Fatty Liver
• Morbid Obesity
• Non-alcoholic Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Obesity
• Obesity, Morbid
• Weight Loss

Intervention

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:
• 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).

Locations

Country	Name	City	State
Mexico	Hospital Juárez de México	Ciudad de México	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Fat tissue	Fat tissue: fat mass in Kilograms and percentage	change from baseline after 6 weeks treatment based on body composition by bioimpedance
Secondary	Metabolic profile	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.
Secondary	Markers of inflammation	Changes in serum markers of inflammation: pg/mL	Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR
Secondary	Surgical complications	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
Secondary	Adverse events 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.