Overview

Weight Loss Aid in an Exposed Population

Status:
Recruiting
Trial end date:
2023-04-30
Target enrollment:
0
Participant gender:
All
Summary
The study will explore whether if the use of Orlistat results in weight loss that is accompanied by a reduction in the body burdens of polybrominated biphenyls (PBB) and other Persistent Organic Pollutants (POPs).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Collaborators:
Healthway Compounding Pharmacy in central Michigan
Michigan Public Health Departments
Treatments:
Orlistat
Criteria
Inclusion Criteria:

- current or recent (within the last five years) serum PBB level of ≥1ppb;or are a
member of a sub-group likely to have high serum PBB (former chemical worker, family
member of former chemical worker, lived on a farm with animals that were quarantined
because of PBB exposure)

- at least 18 years old ;

- currently reside in Michigan;

- able to participate in examinations and laboratory tests (a lipid panel, liver
function test, thyroid function and and creatinine levels) done at at a local health
department or other medical health facility and to be able to engage in moderate
physical activity (e.g. walking);

- participants with undiagnosed abdominal pain or diarrhea, Crohn's disease, Ulcerative
Colitis, Celiac Disease, treated diabetes or treated thyroid disorder, will only be
eligible following consultation with their primary care provider;

- any participant using levothyroxine will be instructed to take their dosage 4 hours
before or after Orlistat in order to maintain eligibility.

Exclusion Criteria:

- BMI<25 ;

- abnormal liver function;

- abnormal creatinine levels;

- abnormal thyroid levels (TSH);

- have type 1 diabetes;

- have had an organ transplant;

- are pregnant or lactating;

- current use of weight-loss medications, oral steroids, Coumadin, warfarin or
Cyclosporine;

- have a diagnosed problem absorbing food, or have an eating disorder;

- a history of bariatric surgery, pancreatitis, kidney stones, gall bladder disorder;
serious chronic disease (e.g. uncontrolled diabetes, congestive heart failure, chronic
kidney disease);

- allergies to any ingredients of the Orlistat OTC capsules( Ingredients of Orlistat
include the active ingredient, Orlistat, and the inactive ingredients, FD&C Blue No.
2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium
lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide);

- participants will become ineligible at any point during the study if they begin a
medical regimen involving any of the above medications.