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

Soroka University Medical Center

Status: Active, not recruiting

Conditions: Diabetes; Bariatric Surgery; Obesity

Treatments: Drug: Oxytocin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05207774

SOR-0041-18-CTIL

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

oxytocin

Experimental group

Description:

8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks

Treatment:

Drug: Oxytocin

placebo

Placebo Comparator group

Description:

intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks

Treatment:

Drug: placebo