Gastric Bypass Clinical Trials

Clinical trials related to Gastric Bypass Procedure

A Prospective Randomized Study Evaluating the Efficacy and Safety of the iCan i3 Continuous Glucose Monitoring System in Post-Bariatric Patients With Late Dumping Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Late dumping syndrome is a common complication following Roux-en-Y gastric bypass, characterized by postprandial hypoglycemia with significant impact on patient safety and quality of life. Traditional capillary glucose monitoring has limited ability to detect rapid glycemic fluctuations. This prospective randomized study aims to evaluate the efficacy and safety of the iCan i3 continuous glucose monitoring (CGM) system compared to conventional capillary glucose monitoring in detecting hypoglycemic events in post-bariatric patients with late dumping syndrome. Participants will be randomized into two groups: one using CGM and one using standard fingerstick monitoring, and followed for 60 days. Clinical outcomes, hypoglycemia frequency, symptom correlation, and quality of life will be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 18-65 years

• History of Roux-en-Y gastric bypass ≥12 months

• Clinical diagnosis of late dumping syndrome

• Stable body weight (\<5% variation in last 3 months)

• Ability to provide informed consent

Locations
Other Locations
Brazil
Kaiser Clínica Hospital Dia
RECRUITING
São José Do Rio Preto
Contact Information
Primary
Roberto Luiz Kaiser Junior, PhD
kaiserjr@kaiserclinica.com.br
+ 55 17 3302-4781
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Arm 1 - Experimental
Continuous Glucose Monitoring (iCan i3)
Active_comparator: Arm 2 - Active Comparator
Capillary Glucose Monitoring (fingerstick using glucometer)
Related Therapeutic Areas
Sponsors
Leads: Kaiser Clinic and Hospital

This content was sourced from clinicaltrials.gov