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Orlistat/Phentermine Versus Placebo/Phentermine

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Orlistat 120Mg Cap
Phentermine Pill
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  1. 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)
  2. 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
  3. Uncontrolled hypertenstion (SBP>180mmHg or DBP >120mmHg)
  4. Under taking anti-diabetics or fasting blood glucose >=200mg/dl
  5. If your weight has decreased by more than 5 kg in the last 3 months
  6. (AST or ALT> 3 times the normal value) or kidney disease (serum creatinine> 2.0 mg / dL)
  7. Patients taking other clinical trial drugs
  8. Patients taking other appetite suppressants within the last 30 days
  9. Acute infectious diseases such as pneumonia, acute enteritis, and acute urinary tract infections
  10. If you are participating in other clinical trials
  11. Those who are deemed unsuitable for participating in this study by the researcher

Sites / Locations

  • Yongin Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

orlistat

placebo

Arm Description

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)

placebo (120mg, three times a day, within 1hour after meal) combined with phentermine pill (37.5mg, once a day, within 1hour after meal)

Outcomes

Primary Outcome Measures

Body mass index changes
Body mass index in kg/m2.
Vascular function changes
Vascular function will be assessed using the flow mediated dilatation (%).

Secondary Outcome Measures

Back pain
Assessments using a Visual Analog Score for pain Visual Analog Scale (total score 10, minimum;0, no pain, maximum; 10, severe pain)

Full Information

First Posted
August 28, 2018
Last Updated
October 31, 2019
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03675191
Brief Title
Orlistat/Phentermine Versus Placebo/Phentermine
Official Title
The Effects of Orlistat/Phentermine Versus Placebo/Phentermine Treatment on Weight Loss and Vascular Function of Overweight Patients With Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled clinical trials (12 weeks) orlistat (120mg, three times a day, within 1hour after meal) + phentermin (37.5mg, once a day, within 1hour after meal) placebo (120mg, three times a day, within 1hour after meal) + phentermin (37.5mg, once a day, within 1hour after meal) 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)
Masking
ParticipantCare ProviderInvestigator
Masking Description
The placebo pill is given to participants who are randomly assigned to the control group. Double-blinded
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
orlistat
Arm Type
Experimental
Arm Description
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)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo (120mg, three times a day, within 1hour after meal) combined with phentermine pill (37.5mg, once a day, within 1hour after meal)
Intervention Type
Drug
Intervention Name(s)
Orlistat 120Mg Cap
Other Intervention Name(s)
Lipidown Cap
Intervention Description
Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal
Intervention Type
Drug
Intervention Name(s)
Phentermine Pill
Other Intervention Name(s)
Phentermine Pill 37.5mg
Intervention Description
Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
Primary Outcome Measure Information:
Title
Body mass index changes
Description
Body mass index in kg/m2.
Time Frame
12weeks
Title
Vascular function changes
Description
Vascular function will be assessed using the flow mediated dilatation (%).
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
Back pain
Description
Assessments using a Visual Analog Score for pain Visual Analog Scale (total score 10, minimum;0, no pain, maximum; 10, severe pain)
Time Frame
12weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yongin Severance Hospital
City
Yongin-si
State/Province
Gyeonggi-do
ZIP/Postal Code
17046
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33688228
Citation
Kwon YJ, Lee H, Nam CM, Chang HJ, Yoon YR, Lee HS, Lee JW. Effects of Orlistat/Phentermine versus Phentermine on Vascular Endothelial Cell Function in Obese and Overweight Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial. Diabetes Metab Syndr Obes. 2021 Mar 2;14:941-950. doi: 10.2147/DMSO.S300342. eCollection 2021.
Results Reference
derived

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Orlistat/Phentermine Versus Placebo/Phentermine

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