Orlistat/Phentermine Versus Placebo/Phentermine

October 31, 2019 updated by: Ji-Won Lee, Gangnam Severance Hospital

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

Completed

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

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 17046
        • Yongin Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal
Other Names:
  • Lipidown Cap
Drug: Phentermine Pill
Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
Other Names:
  • Phentermine Pill 37.5mg
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
Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
Other Names:
  • Phentermine Pill 37.5mg

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

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

July 12, 2019

Study Completion (Actual)

August 12, 2019

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2018-0210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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