Status:
UNKNOWN
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Lead Sponsor:
Soroka University Medical Center
Collaborating Sponsors:
Ben-Gurion University of the Negev
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05207774
Start Date
January 9 2020
End Date
August 30 2025
Last Update
January 26 2022
Active Locations (1)
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1
Soroka Unuversity Medical Center
Beersheba, Israel, 8410101