Overview

LOSS- Louisiana Obese Subjects Study

Status:
Terminated
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pennington Biomedical Research Center
Collaborator:
Louisiana Office of Group Benefits
Treatments:
Diethylpropion
Orlistat
Sibutramine
Criteria
Inclusion Criteria:

- Participant in the Exclusive Provider Organization (EPO), Managed Care Organization
(MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State
Employees Group Benefits Health Insurance

- Agree to travel for treatment to the assigned study site

- Agree to randomized treatment assignment

- Male and females age 20-60 years

- Body Mass Index >40kg/m2 but < 60 kg/m2

- Females must be non-pregnant and using an approved contraception method

- Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless
waived by Principal Investigator (PI)

- Uric Acid <9.0 mg/dl

- Normal Creatinine

- Normal Thyroid Stimulating Hormone (TSH)

- Negative urine pregnancy test for women of childbearing potential

- Able to give written informed consent

- Able to comply with study procedures

Exclusion Criteria:

Factors that may limit adherence to interventions or affect conduct of the trial:

- Unable or unwilling to give informed consent or communicate with local study staff

- Hospitalization for psychiatric illness or substance use/abuse within the past year

- Self-report of alcohol or substance abuse within the past twelve months

- Current major depressive episode or history of suicidal behaviors

- Endorsement of significant recent suicidal ideation (as determined by PI)

- Travel plans that do not permit participation

- History of prior bariatric surgery, small bowel resection, or extensive bowel
resection

- Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic
medication, herbal medications for weight loss or any medication not approved by the
PI.

- Another member of the household is a participant or staff member in the study

- History of eating disorder such as anorexia nervosa, bulimia, or binge eating

- Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or
personality disorder (as determined by the PI)

- Currently pregnant or nursing or plans to become pregnant in the next five years

- Except for non-melanoma skin cancer, cancer requiring treatment in the past five
years, unless the prognosis is excellent

- Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active
tuberculosis

- Cardiovascular disease event within the past year

- Severe congestive heart failure (New York Heart Association [NYHA] Functional Class
III, IV)

- Second degree or greater heart block

- Blood Pressure >160 systolic or >100 diastolic on two consecutive visits, unless
treated and re-screened

- Based upon responses to psychological screening or an interview, patients may be
excluded by the study psychologist.

- Other medical, psychiatric, or behavioral limitations that in the judgment of the
investigator may interfere with study participation or the ability to follow the
intervention protocol.

- Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or
oophorectomy must have a negative urine pregnancy test result at screening. Women of
childbearing potential will be allowed to participate if they have undergone tubal
ligation, or use one of the following types of contraception: properly used condom or
diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual
abstinence may constitute an acceptable birth control method for this study with
investigator approval. Women with male partners who have had a successful vasectomy
(more than one year of unprotected sexual intercourse without pregnancy) are not
required to use additional birth control methods as long as the relationship remains
exclusive, and the woman agrees to use an approved contraception method with any other
male partner. Questions regarding individual patient contraceptive practices should be
directed to the Principal Investigator.