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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phentermine | Active Comparator | Low-calorie diet + Phentermine Capsules 15 mg po by 6 weeks, one time a day before bariatric surgery. |
|
| Placebo | Placebo Comparator | Low-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Fat tissue | Fat tissue: fat mass in Kilograms and percentage | change from baseline after 6 weeks treatment based on body composition by bioimpedance |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Markers of inflammation |
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Inclusion Criteria:
Exclusion Criteria:
Use of addictive substances
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Pérez-Cruz, MD | Hospital Juárez de México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juárez de México | Mexico City | Mexico City | 07760 | Mexico |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
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double-blinded
|
| 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). |
|
Changes in serum markers of inflammation: pg/mL
| Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR |
| 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 |
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001836 | Body Weight Changes |
| Organic Chemicals |