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.