- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675191
Orlistat/Phentermine Versus Placebo/Phentermine
The Effects of Orlistat/Phentermine Versus Placebo/Phentermine Treatment on Weight Loss and Vascular Function of Overweight Patients With Back Pain
The prevalence of obesity is increasing worldwide and obesity is an important risk factor for cardiovascular disease. In addition, back pain has been increasing steadily due to sitting life, lack of exercise, wrong posture, and obesity. Recent studies found that obesity and back pain are common diseases and are closely related to each other. People with back pain have lower physical activity, which in turn leads to an weight gain and a deterioration in physical performance. Among the drugs used for obesity, orlistat has been approved for long-term use, and phentermine, the most commonly used drug, has been approved for short-term use. However, phentermine can increase blood pressure and pulse rate. Meanwhile, several studies have shown that orlistat, a pancreatic lipase inhibitor, lowers blood pressure and pulse rate and diminish LDL-cholesterol. Lowering LDL-C could lead to improved vascular endothelial function.
The investigators aimed to investigate the effect of orlistat and phentermine combination therapy on weight loss and improvement of vascular function compared to phentermine monotherapy in obese patients (BMI 27 kg/m2) with metabolic risk and back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators aimed to investigate the effect of orlistat and phentermine combination therapy on weight loss and improvement of vascular function compared to phentermine monotherapy in obese patients (BMI 27 kg/m2) with metabolic risk and back pain.
Randomized placebo-controlled clinical trials (12 weeks), Patients: Obese patients (BMI 27 kg/m2) with metabolic risk and back pain
The patients were divided into two groups: orlistat (120mg, three times a day), phentermine (37.5 mg, once a day) combined Group (N = 57), placebo (placebo, three times a day) and phentermine (37.5 mg, once a day) Group (N=57).
Randomly assigned to each group at 1: 1, and allocation codes are generated using SAS (Ver. 9.2). The investigators provide orlistat and phentermine or placebo and phentermine. The investigators check physical measurement, blood test, questionnaire, blood pressure and pulse, body composition, FMD, heart rate variability test, in the first visit. The investigators check for changes in body weight, compliance, and side effects after 4 weeks and 8 weeks, respectively. After 12 weeks, the investigators re-check physical measurement, blood test, questionnaire, blood pressure and pulse, body composition, FMD, heart rate variability test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
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Yongin-si, Gyeonggi-do, Korea, Republic of, 17046
- Yongin Severance Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- After a screening test, the characteristics of the trial were explained and then the patient voluntarily agreed to participate in the study and signed a consent form with IRB approval.
- Adults over 20 years of age at the time of obtaining consent
- A back pain score of 3 and a metabolic risk of a BMI greater than 27 kg / m2.
- Metabolic risk includes the following, according to the American Endocrinology Society (AACE) guidelines. (Diabetic stage, metabolic syndrome, type 2 diabetes, dyslipidemia, hypertension, cardiovascular disease, nonalcoholic fatty liver, polycystic ovary syndrome, obstructive sleep apnea, osteoarthritis, gastroesophageal
- In the case of a pregnant woman, pregnancy test is negative
- Patients who can understand and speak Korean
- Patients whose physicians approved to participate in the study
- Patients who are able to complete the study without participating in other intervention studies (drug, diet, exercise intervention studies) during the study period.
- Patients who agreed to contraception during the study
Exclusion Criteria:
- Persons who are contraindicated for Phentermine Sympathomized excitable amines sensitive patients or patients with specific qualities Progressive arteriosclerosis patients Patients with symptomatic cardiovascular disease When there is pulmonary hypertension or heart valve disease A patient with hyperthyroidism A patient with glaucoma Patients who are extremely anxious or excited mentally person who had history of drug abuse Patients taking other central nervous system stimulants or those 14 days after the administration of MAO inhibitors (MAOIs)
- Persons who are contraindicated for Orlistat Patient with chronic malabsorption syndrome or patient who stops secretion of juice Patients with hypersensitivity to this or this component
- Uncontrolled hypertenstion (SBP>180mmHg or DBP >120mmHg)
- Under taking anti-diabetics or fasting blood glucose >=200mg/dl
- If your weight has decreased by more than 5 kg in the last 3 months
- (AST or ALT> 3 times the normal value) or kidney disease (serum creatinine> 2.0 mg / dL)
- Patients taking other clinical trial drugs
- Patients taking other appetite suppressants within the last 30 days
- Acute infectious diseases such as pneumonia, acute enteritis, and acute urinary tract infections
- If you are participating in other clinical trials
- Those who are deemed unsuitable for participating in this study by the researcher
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: orlistat
Orlistat 120Mg Cap (120mg, three times a day, within 1hour after meal) combined with phentermine pill (37.5mg, once a day, within 1hour after meal)
|
Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal
Other Names:
Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
Other Names:
|
Placebo Comparator: placebo
placebo (120mg, three times a day, within 1hour after meal) combined with phentermine pill (37.5mg, once a day, within 1hour after meal)
|
Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index changes
Time Frame: 12weeks
|
Body mass index in kg/m2.
|
12weeks
|
Vascular function changes
Time Frame: 12weeks
|
Vascular function will be assessed using the flow mediated dilatation (%).
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Back pain
Time Frame: 12weeks
|
Assessments using a Visual Analog Score for pain Visual Analog Scale (total score 10, minimum;0, no pain, maximum; 10, severe pain)
|
12weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Body Weight
- Overweight
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Lipid Regulating Agents
- Appetite Depressants
- Anti-Obesity Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Orlistat
- Phentermine
Other Study ID Numbers
- 3-2018-0210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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