Back to resultsAssess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sibutramine
Orlistat
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity
Eligibility Criteria
MAOInclusion Criteria:
- A patient who gave one's voluntary written consent to participate in this clinical study
- Aged ≥ 18 and < 50 years old
- An obese patient with a body mass index (BMI) ≥ 27 kg/m2
- In case of a women, premenopausal woman
Exclusion Criteria:
- A patient with the weight change ≥ 5% over the past 3 months
- A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
- A patient with an active acute or chronic disease at the participation of the study
- A patient with the malignancy history within the past 5 years
- A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
- A patient with a significant cardiovascular disease (coronary vascular disease, congestive heart failure, peripheral arterial obstructive disease, arrhythmia, cerebrovascular disease, etc.), poorly controlled hypertension defined by JNC(Joint National Committee) 7 guidelines, diabetes, severe hepatic/renal disease and CNS(Central Nervous System) disease, drug abuse, psychiatric disorder, positive prostatic hyperplasia concurrent with urinary retention and glaucoma within the past 1 year according to medical records
- A patient falling under the followings from screening test results Hemoglobin < 10g/L or platelets < 100* 103/μL Total bilirubin > 2.0mg/dL Serum GOT(Glutamate oxaloacetate transaminase) or GPT(glutamic pyruvate transaminase) > 120 IU/L Serum creatinine > 1.4mg/dL Serum uric acid > 10mg/dL Thyroid stimulating hormone < 0.1μIU/mL or > 6.5 μIU/mL
- A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
- A pregnant women or breastfeeding mother
- A patient participating in another clinical study other than this study
- Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
- A person who participated in other clinical study within the past 3 months
Sites / Locations
- GachonGill Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sibutramine + Orlistat
Sibutramine + Orlistat(Placebo)
Arm Description
A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence
Sibutramine : one of components included into Diet Pills. This reduces appetite, normalizes amount of cholesterol in blood, and reduces abdominal fat. Orlistat : A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence.
Outcomes
Primary Outcome Measures
Weight
Weight
BMI(Body Mass Index)
BMI(Body Mass Index)
waist circumference
waist circumference
blood pressure
blood pressure
fat mass
fat mass
visceral fat mass improvement
visceral fat mass improvement
Secondary Outcome Measures
Lipid profile
Total cholesterol, HDL-C(high-density lipoprotein-cholesterol), LDL-C(low-density lipoprotein-cholesterol), Triglyceride improvement
Adipokines improvement
Serum insulin, adiponectin, leptin, ghrelin, serum ostecalcin, urine deoxypyridinolin
Full Information
NCT ID
NCT01184560
First Posted
August 16, 2010
Last Updated
August 18, 2010
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01184560
Brief Title
Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
Official Title
A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Study to Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study, conducted academic Pilot research purposes, this is not clear as to permit. when orlistat to sibutramine merge if there are additional effects of BMI and group, which has an attribute that is greater for the combined effect is to analyze.
Study phase: Investigator-initiated clinical study (Pilot study)
Method of blinding: Double-blind
Control: Placebo-controlled
Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and Sibutramine combination group = 1 : 1)
Studied disease: Obesity
Study population: Subjects eligible for inclusion/exclusion criteria
Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and post-dosing observation period (4 weeks)
Detailed Description
After the screening period, patients eligible for inclusion/exclusion criteria would administer Sibutramine placebo and Orlistat placebo during 2 weeks of the run-in period, Subsequently, subjects are randomized to 2 groups of the Sibutramine monotherapy group and the Orlistat and Sibutramine combination group. Sibutramine monotherapy group would receive Sibutramine 10mg once daily and Orlistat placebo three times daily for 12 weeks; the Orlistat and Sibutramine combination group would receive Sibutramine 10mg once daily and Orlistat 120mg three times daily for 12 weeks. After completing the dosing period, the occurrence of adverse events would be checked for 4 weeks and the study would be completed.
Body weight, abdominal CT(Computed Tomography)(visceral fat examination), body fat analysis, etc. would be measured before the study initiation and after 14 weeks of treatment, and comparatively analyzed. A two sample t-test is conducted for the inter-group comparison and a paired t-rest is conducted for the comparison between baseline and after 14 weeks after the study initiation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sibutramine + Orlistat
Arm Type
Experimental
Arm Description
A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence
Arm Title
Sibutramine + Orlistat(Placebo)
Arm Type
Placebo Comparator
Arm Description
Sibutramine : one of components included into Diet Pills. This reduces appetite, normalizes amount of cholesterol in blood, and reduces abdominal fat.
Orlistat : A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence.
Intervention Type
Drug
Intervention Name(s)
Sibutramine
Intervention Description
○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.
Treatment period: The total dosing period is 12 weeks.
Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily
Intervention Type
Drug
Intervention Name(s)
Orlistat
Intervention Description
○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.
Treatment period: The total dosing period is 12 weeks.
Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily
Primary Outcome Measure Information:
Title
Weight
Description
Weight
Time Frame
with in 18weeks
Title
BMI(Body Mass Index)
Description
BMI(Body Mass Index)
Time Frame
with in 18weeks
Title
waist circumference
Description
waist circumference
Time Frame
with in 18weeks
Title
blood pressure
Description
blood pressure
Time Frame
with in 18weeks
Title
fat mass
Description
fat mass
Time Frame
with in 18weeks
Title
visceral fat mass improvement
Description
visceral fat mass improvement
Time Frame
with in 18weeks
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Total cholesterol, HDL-C(high-density lipoprotein-cholesterol), LDL-C(low-density lipoprotein-cholesterol), Triglyceride improvement
Time Frame
with in 18weeks
Title
Adipokines improvement
Description
Serum insulin, adiponectin, leptin, ghrelin, serum ostecalcin, urine deoxypyridinolin
Time Frame
with in 18weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
MAOInclusion Criteria:
A patient who gave one's voluntary written consent to participate in this clinical study
Aged ≥ 18 and < 50 years old
An obese patient with a body mass index (BMI) ≥ 27 kg/m2
In case of a women, premenopausal woman
Exclusion Criteria:
A patient with the weight change ≥ 5% over the past 3 months
A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
A patient with an active acute or chronic disease at the participation of the study
A patient with the malignancy history within the past 5 years
A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
A patient with a significant cardiovascular disease (coronary vascular disease, congestive heart failure, peripheral arterial obstructive disease, arrhythmia, cerebrovascular disease, etc.), poorly controlled hypertension defined by JNC(Joint National Committee) 7 guidelines, diabetes, severe hepatic/renal disease and CNS(Central Nervous System) disease, drug abuse, psychiatric disorder, positive prostatic hyperplasia concurrent with urinary retention and glaucoma within the past 1 year according to medical records
A patient falling under the followings from screening test results Hemoglobin < 10g/L or platelets < 100* 103/μL Total bilirubin > 2.0mg/dL Serum GOT(Glutamate oxaloacetate transaminase) or GPT(glutamic pyruvate transaminase) > 120 IU/L Serum creatinine > 1.4mg/dL Serum uric acid > 10mg/dL Thyroid stimulating hormone < 0.1μIU/mL or > 6.5 μIU/mL
A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
A pregnant women or breastfeeding mother
A patient participating in another clinical study other than this study
Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
A person who participated in other clinical study within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Kyoungkon
Organizational Affiliation
GachonGill Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
GachonGill Medical Center
City
Inchon
State/Province
Namdong-gu
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25280441
Citation
Ko KD, Kim KK, Suh HS, Hwang IC. Associations between the GNB3 C825T polymorphism and obesity-related metabolic risk factors in Korean obese women. J Endocrinol Invest. 2014 Nov;37(11):1117-20. doi: 10.1007/s40618-014-0182-6. Epub 2014 Oct 4.
Results Reference
derived
PubMed Identifier
24411757
Citation
Kim KK, Suh HS, Hwang IC, Ko KD. Influence of eating behaviors on short-term weight loss by orlistat and anorectic agent. Eat Behav. 2014 Jan;15(1):87-90. doi: 10.1016/j.eatbeh.2013.10.019. Epub 2013 Oct 31.
Results Reference
derived
PubMed Identifier
24262967
Citation
Hwang IC, Park JY, Ahn HY, Kim KK, Suh HS, Ko KD, Kim KA. Effects of CYP3A5, CYP2C19, and CYP2B6 on the clinical efficacy and adverse outcomes of sibutramine therapy: a crucial role for the CYP2B6*6 allele. Clin Chim Acta. 2014 Jan 20;428:77-81. doi: 10.1016/j.cca.2013.11.007. Epub 2013 Nov 19.
Results Reference
derived
PubMed Identifier
23061407
Citation
Hwang IC, Kim KK, Ahn HY, Suh HS, Oh SW. Effect of the G-protein beta3 subunit 825T allele on the change of body adiposity in obese female. Diabetes Obes Metab. 2013 Mar;15(3):284-6. doi: 10.1111/dom.12023. Epub 2012 Nov 8.
Results Reference
derived
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Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
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