Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

This study has been completed.
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01184560
First received: August 16, 2010
Last updated: August 18, 2010
Last verified: October 2009
  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

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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.

  • 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
Drug: Orlistat

○ 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
Placebo Comparator: Sibutramine + Orlistat(Placebo)
  1. Sibutramine : one of components included into Diet Pills. This reduces appetite, normalizes amount of cholesterol in blood, and reduces abdominal fat.
  2. 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.
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.

  • 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
Drug: Orlistat

○ 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

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
Criteria

MAOInclusion Criteria:

  1. A patient who gave one's voluntary written consent to participate in this clinical study
  2. Aged ≥ 18 and < 50 years old
  3. An obese patient with a body mass index (BMI) ≥ 27 kg/m2
  4. In case of a women, premenopausal woman

Exclusion Criteria:

  1. A patient with the weight change ≥ 5% over the past 3 months
  2. A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
  3. A patient with an active acute or chronic disease at the participation of the study
  4. A patient with the malignancy history within the past 5 years
  5. A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
  6. 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
  7. 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
  8. A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
  9. A pregnant women or breastfeeding mother
  10. A patient participating in another clinical study other than this study
  11. Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
  12. A person who participated in other clinical study within the past 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184560

Locations
Korea, Republic of
GachonGill Medical Center
Inchon, Namdong-gu, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
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
Orlistat
Sibutramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants

ClinicalTrials.gov processed this record on September 18, 2014