Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
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Purpose
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)
| Condition | Intervention |
|---|---|
|
Obesity |
Drug: Sibutramine Drug: Orlistat |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- Weight [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]Weight
- BMI(Body Mass Index) [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]BMI(Body Mass Index)
- waist circumference [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]waist circumference
- blood pressure [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]blood pressure
- fat mass [ Time Frame: with in 18weeks ]fat mass
- visceral fat mass improvement [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]visceral fat mass improvement
- Lipid profile [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]Total cholesterol, HDL-C(high-density lipoprotein-cholesterol), LDL-C(low-density lipoprotein-cholesterol), Triglyceride improvement
- Adipokines improvement [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]Serum insulin, adiponectin, leptin, ghrelin, serum ostecalcin, urine deoxypyridinolin
| Enrollment: | 174 |
| Study Start Date: | February 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sibutramine + 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
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Drug: Sibutramine
○ 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.
○ 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.
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Placebo Comparator: Sibutramine + Orlistat(Placebo)
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Drug: Sibutramine
○ 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.
○ 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Korea, Republic of | |
| GachonGill Medical Center | |
| Inchon, Namdong-gu, Korea, Republic of | |
| Principal Investigator: | Kim Kyoungkon | GachonGill Medical Center |
More Information
No publications provided by Gachon University Gil Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kyoungkon Kim/Principal Investigator, GachonGill Medical Center |
| ClinicalTrials.gov Identifier: | NCT01184560 History of Changes |
| Other Study ID Numbers: | HM-OPS |
| Study First Received: | August 16, 2010 |
| Last Updated: | August 18, 2010 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Gachon University Gil Medical Center:
|
obesity |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes Sibutramine Orlistat |
Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013