Polybrominated Biphenyl Poisoning Clinical Trial
Official title:
Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)
| Verified date | March 2024 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Michele Marcus | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University | Healthway Compounding Pharmacy in central Michigan, Michigan Public Health Departments, National Institute of Environmental Health Sciences (NIEHS) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight | Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale. | Enrollment, Month 3, Month 6 | |
| Primary | Body Mass Index (BMI) | Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight. Participants had their weight measured in light clothing without shoes on a regularly calibrated digital scale. Height is measured using a well-mounted stadiometer. | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of Polybrominated Biphenyl (PBB) 153 | PBB is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. PBB 153 concentration in serum is measured in nanograms per milliliter (ng/mL). | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47 | PBDE is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. PBDE 47 concentration in serum is measured in ng/mL. | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of Polychlorinated Biphenyl (PCB) 118 | PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 118 concentration in serum is measured in ng/mL. | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of PCB 138 | PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 138 concentration in serum is measured in ng/mL | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of PCB 153 | PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 153 concentration in serum is measured in ng/mL. | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of PCB 180 | PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 180 concentration in serum is measured in ng/mL | Enrollment, Month 3, Month 6 | |
| Secondary | Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) | DDE is a chemical produced by the breakdown of dichlorodiphenyltrichloroethane (DDT). High levels of DDE can impact lactation and increase the risk of preterm birth. DDE concentration in serum is measured in ng/mL. | Enrollment, Month 3, Month 6 |