Please note: This trial has finished recruiting and is not accepting new participants.

Research Center: Joslin Diabetes Center
Location: 1 Joslin Pl, Boston, MA 02215, United States
Lead Researcher: Mary Elizabeth Patti, MD
IRB Committee: This study has been reviewed and approved by the Joslin Institutional Review Board

Background

 

Bariatric surgery is increasingly recognized as a useful tool for weight loss and improving metabolism.   However, some individuals develop low blood sugars (hypoglycemia) after bariatric surgery, which can be severe.  This is called post-bariatric hypoglycemia (PBH).

This study seeks to learn more about the causes of post-bariatric hypoglycemia or low blood sugar among individuals who have had gastric bypass bariatric surgery.  

Interested participants must be 18 to 70 years old who have undergone gastric bypass surgery. Participants must be willing to comply with all the necessary study requirements.

Why Participate? 

 

• You may contribute valuable information that may be used to develop future treatments for hypoglycemia.
• You may help researchers understand the causes of hypoglycemia among those who have experienced it following bariatric surgery.
• You will be compensated for participating in this study, parking will be provided, and monetary compensation will be available to help cover travel expenses. 
• You will be provided with meals during some of the study visits.
• You will be helping to advance medical research.

Your Rights

 

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

 

• Adults aged 18 to 70 years old who have undergone a bariatric surgery in the form of a Roux-en-Y gastric bypass (RYGB).
• Participants must not currently have diabetes. 
• Participants must not have any alcohol or substance use disorders.
• Able to attend 4 study visits at the research site for over approximately 2 months.
  • The first study visit will last about 2 hours, the second will last about 6 hours, the third visit will last about 5 hours and the fourth visit will last about 7 hours.
  • This study will involve a physical exam, medical history taking, EKG assessment, blood testing, and intravenous (IV) lines. 
  • Participants will need to wear a continuous glucose (blood sugar) monitor for 10 days.

About The Research Centers:

 

Please note:

 

Due to the current situation with COVID-19 pandemic, the study team would like to point out the following:

• The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
• The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
• Hand sanitisers are available at the research site.
• The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19. 
• Any staff suspected to have COVID-19, or has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
• Interested participants will not be left waiting for a long period of time and will be quickly attended to. 
• Parking is available at the research site and vouchers are provided with participation.
• The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. 
• The research site/institution is taking all precautionary measures to ensure the safety of the study participants.