Flourish Research - San Antonio

Obesity Research Study Self-Scheduler (18-80 yrs old)

Basic Criteria: 

  • Be 18-80 years of age  
  • Qualified participants must have a BMI of between 30-42 (Click the link to calculate
  • Have a history of at least one unsuccessful dietary effort to lose body weight.  
  • Hypertension or hyperlipidemia, must be controlled with stable dose/therapy on study and for the 3 months prior to Day 1.

Answers Must Be No 

  • Is your obesity related to endocrinological disorders? 
  • Have any prior diagnosis of diabetes Type 1 or Type 2 or a rare form of diabetes? 
  • Are you currently or have you participated in an organized weight reduction program in the last 3 months? 
  • Do you have a history of significant major depressive disorders or other psychiatric disorders that also include suicidal behaviors? (Schizophrenia, bipolar disorder, major mood or anxieties) 
  • FEMALES- Are you currently pregnant or breastfeeding? 
  • FEMALES- Are you of childbearing potential? If so, are you using the following highly effective birth control methods: 
    • Intrauterine devices (IUD) 
    • Intrauterine hormone-releasing system (IUS) 
    • Bilateral tubal occlusion or ligation
    • Azoospermia (zero sperm count) partner either vasectomized or is unable to produce sperm due to medical condition.  
    • Combined (estrogen and progestogen) hormonal contraception including oral pills, intravaginal rings, transdermal patch, and injectable forms.

Exceptions are mild depression, and mild anxiety must be stable for 3 months prior to day 1. 

  • Have a history of clinically significant gastric emptying abnormality? (the time it takes for food to empty stomach) 
  • Are you taking drugs that affect GI motility? (the normal movement of food through the digestive tract) 
  • Have you had surgical treatment for obesity including gastric bypass, restrictive bariatric surgery, endoscopic or device-based therapy within the year or plans to undergo surgical treatment for obesity including endoscopic or device-based therapy? 

Exceptions: 

Liposuction or tummy tuck >1 year prior is eligible 

Endoscopic procedure or removal of device-based therapy (e.g. Lap-band, Duodenal-jejunal bypass sleeve) >1 year prior is eligible. 

  • Have you had a heart attack, chest pain (angina) or stroke within the last 6 months? 
  • Are you currently in heart Failure class five? (Symptoms of heart failure at rest. Any physical activity causes further discomfort) 
  • Do you have uncontrolled high blood pressure, high cholesterol, low blood pressure, arrythmias, or abnormal ECGs even with stable doses of medication?  

Exceptions: 

High blood pressure must be controlled with a mean seated blood pressure of 140/90 and high cholesterol with stable medication for 3 months prior to day 1. 

  • Do you have a history of cancer within the last 5 years? 

Exceptions: 

Fully excised nonmelanoma skin cancers or nonmetastatic prostate cancer must have been stable equal or greater than 6 months. 

  • Do you currently have an active infectious disease, or have you been hospitalized for a serious infection in the last three months? 
  • Do you currently abuse drugs or alcohol? 
  • Do you have any history of immunodeficiencies or autoimmune diseases? 
  • Do you have chronic liver disease stage 3 or 4, acute kidney injury, or presence of gallbladder disease? 
  • Do you have chronic pancreatitis or a presence of pancreatitis in the last 180 days? 
  • Do you currently have gastric ulcers or a recent history within the last 3 months? 
  • Do you have a personal or familial history of medullary thyroid carcinoma (cancer that forms inside your thyroid gland) or multiple endocrine neoplasia type 2 (causes tumors in the thyroid and parathyroid glands, adrenal glands, lips, mouth, eyes and digestive tract)? 
  • Do you currently use any medications, nutritional supplements or over the counter weight loss products for weight loss within the last 6 months? 
  • Do you have any current or history of medication that caused significant weight gain within the last 3 months? 

Exceptions: 

Corticosteroids must be stable for at least 3 months. 

  • Have you participated in any other investigation therapy or device within 90 days? 
  • Have you received any live vaccinations within the last 28 days or plans to receive one? 

Exceptions: 

Non live vaccines ex Covid vaccine 

  • Are you currently taking of the following: 
    • Immunosuppressive biologic or targeted therapy within 90 days?
    • Use of anti-inflammatories medication of no more than 800 MG/day within 30 days? (ibuprofen)
    • Use of Colchicine within 30 days?
    • Glucose -lowering agents for conditions other than diabetes in 90 days?
    • Unable or unwilling to stop anticoagulants medications during a certain part of the study? 
  • Are you anticipating changing (start, stop, or change in dose) to any concomitant therapies? 
  • Plans to start, stop or change thyroid treatment within 2 months? 
  • Plans to start stop or change ADHD treatment within 3 months? 

 

Answers Must Be Yes 

  • Have you had a history of at least 1 unsuccessful dietary effort to lose body weight? 
  • Has your body weight been stable for at least 3 months? 
  • MALES- Are you willing to refrain from donating sperm during the study and 90 days after last dose? 
  • MALES- Are you willing to use condoms? 
  • Are you willing to comply with study requirements and restrictions?  

 

Compensation may be available for time and travel

  Insurance is not required 

  

PLEASE NOTE: Please confirm your eligibility before your appointment by calling : 210.714.0067

 If you do not see an available appointment, please call: 210.714.0067 for availability 

 Transportation may be available. Call : 210.714.0067

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