Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Sponsor

Hospital Juarez de Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT03849729

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.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 :

Mar 1, 2018

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

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 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).

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 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).

Outcome Measures

Primary Outcome Measures

Number of participants with Intrahepatic fat [Change from baseline after 6 weeks treatment based on hepatic ultrasound.]
Intrahepatic fat semi-qualitative asessment: mild(<20%), moderate (20-30%), severe (>30%)
Fat tissue [change from baseline after 6 weeks treatment based on body composition by bioimpedance]
Fat tissue: fat mass in Kilograms and percentage

Secondary Outcome Measures

Metabolic profile [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
Markers of inflammation [Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR]
Changes in serum markers of inflammation: pg/mL
Surgical complications [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
Adverse events associated with phentermine [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