Weight loss for overweight patients with high blood pressure, type II diabetes
TIME AND TRAVEL COMPENSATION $125.00 PER office study VISIT.
The study medication is in form of pills taken by mouth. )
Ages 18 and older.
All related tests and treatments are at NO charge to you:
- Examination
- Medication
- Study related lab tests
- EKG of heart if needed
Read more detail Please Scroll down to the bottom of this page. :
Pharmaceutical name: Mineralys Therapeutical
It has been estimated that 1 billion adults worldwide have obstructive sleep apnea (OSA),
Testing this study drug which has the potential to reduce upper airway obstruction as well as reduce the effects of nighttime hypertension and loss of nighttime BP dipping (Laffin 2023), thus improving the cardiovascular risk profile in obese individuals with moderate to severe OSA. This clinical trial will provide an initial proof-of-concept for these hypotheses.
The goal of this research study is to determine if the investigational drug has the following key benefits:
1- Prior study phases have shown at least 5% weight loss on over 50% of the patients, from start of taking the study medication.
2- other benefits include improvements in several weight-related cardiometabolic parameters eg:.
a- Waist size / circumference,
b- Triglycerides
c-High-density lipoprotein (HDL) cholesterol
d- High-sensitivity C-reactive protein
e- As well as clinically significant improvements in glycemic control (placebo-corrected decrease in
hemoglobin A1c (HbA1c) in subjects with obesity or who are overweight with type 2 diabetes.
Who Can Participate in This Study?
- 18 years of age or older
- Has been diagnosed with Obstructive Sleep Apnea
- Has been prescribed or given CPAP but, Not currently using CPAP treatment
What Will Happen in This Study?
Prior to joining the study, you will review the Informed Consent document with the study doctor. This document will outline and explain everything that will occur during the study, as well as any potential side effects.
During this review, the study doctor will also answer any questions you may have.
After your questions have been answered and you agree to participate in the study, you will have a physical exam and medical tests, including an overnight sleep evaluation.
The tests and sleep evaluation will help to determine whether you can continue to participate in this study.
If you are eligible to continue in the study, you will be assigned to one of two groups. One group will receive the investigational drug, and the other group will receive placebo. Placebo looks like the investigational drug but contains no active medication.
Neither you nor the study team will know which study drug you are taking. This allows study doctors to compare both groups and learn whether the investigational drug may be able to treat sleep apnea.
You will take your study drug every night within 30 minutes of bedtime.
You will work with the study team to schedule your appointments. Most of these appointments will be office visits. You will also have a few overnight sleep evaluations that the study doctor will discuss with you in more detail.
Please know that you will not be charged to participate in this study, and you do not need health insurance. You will also be compensated for your time and travel.
Even if you join this study, you can stop participating at any time and for any reason.
How Can You Join this Study?
If you are interested in participating in this study, please visit SleepApneaTrial.com. On the website, you can answer a few questions, to see if you pre-qualify for this study.
If you pre-qualify, a representative from a local study center will contact you to ask questions about your medical history and current medications, as well as answer any questions.
If the study appears to be a good fit, and you are still interested, the representative will schedule an in-person appointment at the study center, to help determine if you can join the study.
Thank you for your time and interest in this research study.
Remember, new treatment options can only happen with people like you!
According to the World Health Organization, there are around 2 billion overweight adults and
650 million of those are considered to be affected by obesity (body mass index [BMI]
≥30 kg/m2). If current trends continue, it is estimated that 2.7 billion adults will be overweight,
over 1 billion will be affected by obesity, and 177 million adults will be severely affected by
obesity by 2025 (National Heart, Lung, and Blood Institute, 1998). These individuals are at an
increased risk for a variety of chronic comorbid conditions associated with obesity, including
type 2 diabetes, coronary heart disease, hypertension, stroke, dyslipidemia, gallbladder disease,
sleep apnea, certain types of cancer, and osteoarthritis, as well as an increased mortality risk
from all cause