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Trial record 58 of 69 for:    ORLISTAT

LOSS- Louisiana Obese Subjects Study (LOSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00115063
Recruitment Status : Terminated (ethical issues of continuing control group without treatment)
First Posted : June 21, 2005
Results First Posted : June 7, 2010
Last Update Posted : February 22, 2016
Sponsor:
Collaborator:
Louisiana Office of Group Benefits
Information provided by (Responsible Party):
Donna H. Ryan, MD, Pennington Biomedical Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Interventions Behavioral: group sessions
Drug: sibutramine, orlistat, diethylpropion
Behavioral: Low Calorie Diet, Health One
Other: Intensive Medical Combination Therapy for Obesity
Other: Control Condition
Enrollment 390
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Period Title: Overall Study
Started 200 190
Completed 101 86
Not Completed 99 104
Reason Not Completed
Lost to Follow-up             98             104
Death             1             0
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website Total
Hide Arm/Group Description Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach Access to Weight Loss Informational Website sponsored by the Mayo Clinic Total of all reporting groups
Overall Number of Baseline Participants 200 190 390
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 190 participants 390 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
200
 100.0%
190
 100.0%
390
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 190 participants 390 participants
47.2  (0.6) 47.1  (0.6) 47.2  (0.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 190 participants 390 participants
Female
167
  83.5%
159
  83.7%
326
  83.6%
Male
33
  16.5%
31
  16.3%
64
  16.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 190 participants 390 participants
Hispanic or Latino 1 0 1
White 149 147 296
Black or African American 50 43 93
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 200 participants 190 participants 390 participants
200 190 390
1.Primary Outcome
Title Percent Change From Baseline Weight
Hide Description [Not Specified]
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the completers, those that completed the 2 year study visit.
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description:
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Overall Number of Participants Analyzed 101 86
Mean (Standard Error)
Unit of Measure: Percent change
-9.7  (1.3) -0.4  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change in Weight From Baseline in Kilograms (kg)
Hide Description [Not Specified]
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the completers, those that completed the 2 year study visit.
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description:
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Overall Number of Participants Analyzed 101 86
Mean (Standard Error)
Unit of Measure: kg
-12.7  (1.7) -0.5  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the completers, those that completed the 2 year study visit.
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description:
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Overall Number of Participants Analyzed 101 86
Mean (Standard Error)
Unit of Measure: millimeter of mercury (mm Hg)
systolic blood pressure -14.7  (2.4) -8.6  (2.6)
dystolic blood pressure -4.4  (1.8) -3.2  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments P-value for systolic blood pressure mean.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments P-value for dystolic blood pressure mean.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
Hide Description [Not Specified]
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the completers, those that completed the 2 year study visit.
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description:
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Overall Number of Participants Analyzed 101 86
Mean (Standard Error)
Unit of Measure: Percent change
LDL 1.8  (2.4) 0.7  (2.4)
HDL 7.9  (1.8) 1.5  (1.8)
Triglycerides -9.2  (3.5) -4.8  (4.3)
Uric Acid -3.0  (2.4) 3.1  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments P-value for LDL cholesterol
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments P-value for HDL cholesterol
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments P-value for triglycerides
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments P-value for uric acid
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)
Hide Description [Not Specified]
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the completers, those that completed the 2 year study visit.
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description:
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Overall Number of Participants Analyzed 101 86
Mean (Standard Error)
Unit of Measure: mg/dL
2.4  (2.1) 6.7  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Duke Activity Status Index (DASI) Questionnaire Score
Hide Description The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the completers, those that completed the 2 year study visit.
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description:
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Overall Number of Participants Analyzed 101 86
Mean (Standard Error)
Unit of Measure: units on a scale
-2.1  (1.7) -11.6  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Intervention, Access to Weight Loss Informational Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Adverse Event Reporting Description Only serious adverse events were tracked for this study.
 
Arm/Group Title Intensive Medical Intervention Access to Weight Loss Informational Website
Hide Arm/Group Description Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach Access to Weight Loss Informational Website sponsored by the Mayo Clinic
All-Cause Mortality
Intensive Medical Intervention Access to Weight Loss Informational Website
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Medical Intervention Access to Weight Loss Informational Website
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/200 (10.00%)      8/190 (4.21%)    
Cardiac disorders     
Chest heaviness * [1]  1/200 (0.50%)  1 0/190 (0.00%)  0
Elevated blood pressure and mood swings *  1/200 (0.50%)  1 0/190 (0.00%)  0
Chest pain * [2]  2/200 (1.00%)  2 0/190 (0.00%)  0
Death * [3]  1/200 (0.50%)  1 0/190 (0.00%)  0
New-onset atrial fibrillation *  1/200 (0.50%)  1 0/190 (0.00%)  0
Hospitalization for acute myocardial infarction *  0/200 (0.00%)  0 1/190 (0.53%)  1
Gastrointestinal disorders     
Hernia repair *  2/200 (1.00%)  2 0/190 (0.00%)  0
Bleeding duodenal ulcer *  1/200 (0.50%)  1 0/190 (0.00%)  0
Metabolism and nutrition disorders     
Hospitalization for hypokalemia *  0/200 (0.00%)  0 1/190 (0.53%)  1
Musculoskeletal and connective tissue disorders     
Hospitalization for arm fracture *  1/200 (0.50%)  1 0/190 (0.00%)  0
Cervical disk surgery *  1/200 (0.50%)  1 0/190 (0.00%)  0
Total knee replacement surgery *  1/200 (0.50%)  1 1/190 (0.53%)  1
Hospitalization for back surgery *  0/200 (0.00%)  0 1/190 (0.53%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer *  0/200 (0.00%)  0 1/190 (0.53%)  1
Psychiatric disorders     
Hospitalization for hallucinations * [4]  1/200 (0.50%)  1 0/190 (0.00%)  0
Renal and urinary disorders     
Surgery for cyctocele *  1/200 (0.50%)  1 0/190 (0.00%)  0
Hospitalization for nephrolithiasis *  1/200 (0.50%)  1 0/190 (0.00%)  0
Reproductive system and breast disorders     
Hysterectomy *  0/200 (0.00%)  0 1/190 (0.53%)  1
Respiratory, thoracic and mediastinal disorders     
Hospitalization for pneumonia *  1/200 (0.50%)  1 0/190 (0.00%)  0
Hospitalization for asthma and bronchitis *  1/200 (0.50%)  1 0/190 (0.00%)  0
Surgical and medical procedures     
Surgical incision and drainage of abscess *  1/200 (0.50%)  1 0/190 (0.00%)  0
Pacemaker insertion procedure *  0/200 (0.00%)  0 1/190 (0.53%)  1
Hospitalization for stent placement *  0/200 (0.00%)  0 1/190 (0.53%)  1
Vascular disorders     
Hospitalization for coronary stent replacement *  1/200 (0.50%)  1 0/190 (0.00%)  0
Hospitalization for deep vein thrombosis *  1/200 (0.50%)  1 0/190 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Referred to cardiologist
[2]
One patient reported chest pain and underwent a angiograpy, results were normal. A second patient reported chest pain and was hospitalized, diagnosed with dehydration.
[3]
Due to myocardial infarction
[4]
Patient had history of mental illness
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Intensive Medical Intervention Access to Weight Loss Informational Website
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
The study was stopped prematurely for efforts to be focused on assisting the Office of Group Benefits (OGB) in translating a policy that would allow for physician certification in order to offer participants the intensive treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tiffany Prather, RN, CDE
Organization: PenningtonBRC
Phone: 225-763-2979
EMail: tiffany.prather@pbrc.edu
Layout table for additonal information
Responsible Party: Donna H. Ryan, MD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00115063     History of Changes
Other Study ID Numbers: PBRC 25002
First Submitted: June 20, 2005
First Posted: June 21, 2005
Results First Submitted: March 1, 2010
Results First Posted: June 7, 2010
Last Update Posted: February 22, 2016