Orlistat/Phentermine Versus Placebo/Phentermine

NCT03675191 | Completed

• 1 other identifier: 3-2018-0210
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Body mass index changes

  Body mass index in kg/m2.

  12weeks

• Vascular function changes

  Vascular function will be assessed using the flow mediated dilatation (%).

  12weeks

Secondary Outcomes (1)

• Back pain

  12weeks

Study Arms (2)

orlistat

EXPERIMENTAL

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: Phentermine Pill

placebo

PLACEBO COMPARATOR

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

Interventions

Orlistat 120Mg Cap DRUG

Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal

Also known as: Lipidown Cap

orlistat

Phentermine Pill DRUG

Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal

Also known as: Phentermine Pill 37.5mg

orlistat; placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 17046, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33688228 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Orlistat; Capsules; Phentermine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The placebo pill is given to participants who are randomly assigned to the control group. Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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)

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 18, 2018
• Study Start: October 16, 2018
• Primary Completion: July 12, 2019
• Study Completion: August 12, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)