Evaluation of the changes in glycemic and physiologic parameters (sleep, cardioadapatbility parameters) in non-diabetic patients being treated for obesity with GLP1 Agonist and GLP-1/ GIP agonist medications.

Overview

About this study

This initial (pilot) study proposes to follow glycemic control, sleep and activity dynamics of individuals without diabetes identified for initiation of GLP-1 agonists/ GLP-1/GIP agonists from before the start of medication treatment to six months after in an effort to identify the predictors of treatment success. Glycemic control will be monitored using the Ultrahuman M1(UH-M1) continuous glucose monitoring system, while sleep and activity will be measured by the Ultrahuman Ring AIR (UH-RA) on the same user interface. It is proposed that participants will wear the devices for a period of 28 days before the initiation of GLP-1 agonists and up to 12 months post-initiation follow up. A variety of glucose data, heart rate, activity indices will be gathered and tracked through the study period to identify metrics that correlate the most with treatment success.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age greater than 18 years.
  • Qualify for endoscopic sleeve gastroplasty and undergoing the procedure.
  • Willing to wear smart ring and CGM for duration of the study.

Exclusion Criteria:

  • Unable or unwilling to wear smart ring and CGM.
  • Contraindication to ESG.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/17/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rahul Pannala, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
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CLS-20582508

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