Weight Loss Aid in an Exposed Population

Completed · Phase 4 · Has a placebo group

Conditions studied: Polybrominated Biphenyl Poisoning

In brief

This study will explore whether 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).

Key facts

Study ID

NCT03582722

Run by

Emory University

People needed

100

Starts

2018-09-14

Expected to finish

2022-06-30

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 or a serious chronic disease (e.g. uncontrolled diabetes, congestive heart failure, chronic kidney disease)
• allergies to any ingredients of the Orlistat over-the-counter (OTC) capsules
• participants will become ineligible at any point during the study if they begin a medical regimen involving any of the above medications

Where it is running

• Michele Marcus — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.