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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03849729
Other study ID # HJM0367/17-IQF
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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