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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sibutramine + Orlistat | Experimental | 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 + Orlistat(Placebo) | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sibutramine | Drug | ○ 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight | with in 18weeks |
| BMI(Body Mass Index) | BMI(Body Mass Index) | with in 18weeks |
| waist circumference | waist circumference | with in 18weeks |
| blood pressure | blood pressure | with in 18weeks |
| fat mass | fat mass | with in 18weeks |
| visceral fat mass improvement | visceral fat mass improvement | with in 18weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Total cholesterol, HDL-C(high-density lipoprotein-cholesterol), LDL-C(low-density lipoprotein-cholesterol), Triglyceride improvement | with in 18weeks |
| Adipokines improvement | Serum insulin, adiponectin, leptin, ghrelin, serum ostecalcin, urine deoxypyridinolin |
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MAOInclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Kyoungkon | GachonGill Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GachonGill Medical Center | Inchon | Namdong-gu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25280441 | Derived | 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. | |
| 24411757 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C058254 | sibutramine |
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Orlistat | Drug | ○ 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.
|
|
| with in 18weeks |
| 24262967 | Derived | 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. |
| 23061407 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |