Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission

• Status: Active, not recruiting
• Trial end date: 2025-08-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults with diabetes undergoing bariatric surgery. Subjects will be randomized to receive of intranasal oxytocin or placebo (8 units 3 times daily) for 8 weeks prior surgery. Study visits include screening to determine eligibility, CGM will be connected before and after oxytocin administration, and 1 year post surgery. blood tests including oral glucose tolerance test will be done and fat samples will be taken during surgery. The investigator's hypothesis is that oxytocin administration prior bariatric surgery can induce diabetes remission in patients with diabetes

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soroka University Medical Center
• Collaborator: Ben-Gurion University of the Negev
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Age 18-65

• Diabetes Mellitus type 2

• HBA1C < or= 9

• BMI >35

• eligible for bariatric surgery (after a hospital bariatric committee)

• Advanced diarem>6

• Signed an informed consent -

Exclusion Criteria:

• HBA1C above 9

• Prior bariatric surgery in the past 6 years

• secondary diabetes

• steroid therapy

• uncontrolled hypertension(>180/100)

• Arythmia: paroxysmal tachyarythmia or high degree AV-Block