Clinical trial NCT03582722: Weight Loss Aid in an Exposed Population
Official title: Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polybrominated Biphenyl Poisoning
Keywords: Polybrominated Biphenyl Exposure
Gastrointestinal lipase inhibitor
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Healthway Compounding Pharmacy
name: Michigan Public Health Departments
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2018-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Millions of people living in Michigan were exposed to brominated flame retardants (polybrominated biphenyls or PBB) as a result of the largest agricultural disaster in US history. Over the past six years, Emory researchers have tested nearly 900 Michigan residents and determined that 60% still had PBB in their bodies from that disaster. PBB is stored in body fat and the researchers at Emory have been asked by community members if weight loss might reduce their body burdens of PBB and other lipophilic chemicals. In an effort to understand how PBB and other persistent organic pollutants (POPs) are eliminated, the researchers are conducting a randomized trial of orlistat versus placebo.

Orlistat is an over-the-counter product approved by the FDA for weight loss and works by increasing excretion of fat into the stool. Since PBB is stored in body fat, the researchers hypothesize that orlistat may reduce the body burden of PBB and other POPs. This study is a randomized, placebo-controlled trial of orlistat (at the dose available over-the-counter) plus diet and exercise for 6 months in a population with elevated PBB levels. Participants will be healthy overweight adults and orlistat will be taken as directed for the approved indication (weight loss).

Eligibility 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 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

Primary outcomes:
measure: Weight
timeFrame: Enrollment, Month 3, Month 6
measure: Body Mass Index (BMI)
timeFrame: Enrollment, Month 3, Month 6
Secondary outcomes:
measure: Serum Concentration of Polybrominated Biphenyl (PBB) 153
timeFrame: Enrollment, Month 3, Month 6
measure: Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47
timeFrame: Enrollment, Month 3, Month 6
measure: Serum Concentration of Polychlorinated Biphenyl (PCB) 118
timeFrame: Enrollment, Month 3, Month 6
measure: Serum Concentration of PCB 138
timeFrame: Enrollment, Month 3, Month 6
measure: Serum Concentration of PCB 153
timeFrame: Enrollment, Month 3, Month 6
measure: Serum Concentration of PCB 180
timeFrame: Enrollment, Month 3, Month 6
measure: Serum Concentration of Dichlorodiphenyldichloroethylene (DDE)
timeFrame: Enrollment, Month 3, Month 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Michele Marcus
state: Georgia
Study officials:
affiliation: School of Public Health, Emory University
name: Michele Marcus, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: