ObesityPhase 4NCT03849729
Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery
A Phase 4 study testing Phentermine in people with Obesity and Morbid Obesity, run by Hospital Juarez de Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity, Morbid Obesity, Bariatric Surgery
- What is being tested?
- Phentermine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2018to 1 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications 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.
Read the 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.
- Being tested
- Phentermine, Placebo
- Keywords
- Obesity, Obesity treatment, Non-alcoholic Fatty Liver, Weight Loss
- Medical subject headings
- Obesity, Obesity, Morbid, Non-alcoholic Fatty Liver Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhentermineDrug
Also called Terfamex
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).
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Phentermine | Active comparator | Low-calorie diet + Phentermine Capsules 15 mg po by 6 weeks, one time a day before bariatric surgery. Receives: Drug: Phentermine |
| Placebo | Placebo comparator | Low-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Intrahepatic fat
Intrahepatic fat semi-qualitative asessment: mild(<20%), moderate (20-30%), severe (>30%)
Measured: Change from baseline after 6 weeks treatment based on hepatic ultrasound.
Fat tissue
Fat tissue: fat mass in Kilograms and percentage
Measured: change from baseline after 6 weeks treatment based on body composition by bioimpedance
Secondary outcomes (4)
Metabolic profile
Changes in serum metabolic profile: mg/dL
Measured: Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR.
Markers of inflammation
Changes in serum markers of inflammation: pg/mL
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Mar 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ELIZABETH PEREZ CRUZ, Hospital Juarez de Mexico
- Investigators
- Elizabeth Pérez-Cruz, MD, Principal investigator, Hospital Juárez de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849729
- Sponsor's protocol ID
- HJM0367/17-IQF
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03849729
- Acronym / sponsor ID
- HJM0367/17-IQF
- Keywords
- Obesity, Obesity treatment, Non-alcoholic Fatty Liver, Weight Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
| Arm | Type | Receives |
|---|---|---|
| Phentermine | Active comparator | Drug: PhentermineLow-calorie diet + Phentermine Capsules 15 mg po by 6 weeks, one time a day before bariatric surgery. |
| Placebo | Placebo comparator | Other: PlaceboLow-calorie diet + Placebo Capsules po by 6 weeks, one time a day before bariatric surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Use of addictive substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhentermineAlso: TerfamexThis 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). | Drug | Phentermine |
| Placebohis 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 |
Primary outcome
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%)
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
4 secondary outcomes
Metabolic profile
Time frame: Change from baseline after 6 weeks treatment based on glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR.
Markers of inflammation
Time frame: Change from baseline after 6 weeks treatment based on IL-1, IL-6 and PCR
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Pérez-Cruz, MD principal investigator
Hospital Juárez de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phentermine in people with Obesity and Morbid Obesity, run by Hospital Juarez de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Intrahepatic fat (time frame: Change from baseline after 6 weeks treatment based on hepatic ultrasound.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.