Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of participants with diabetes remission 1 year post surgery
Study Overview
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 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-65
- •Diabetes Mellitus type 2
- •HBA1C < or= 9
- •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
Arms & Interventions
oxytocin
8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Intervention: Oxytocin (Drug)
placebo
intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with diabetes remission 1 year post surgery
Time Frame: 1 year post surgery
HBA1C less then 6.5% without need for diabetes medication
Number of participants who improved their glycemic control
Time Frame: 8 weeks
increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
weight loss
Time Frame: 1 year
weight reduction - kg.
obesity
Time Frame: 1 year
change in waist circumference
Secondary Outcomes
- lipids-NON HDL CHOLESTEROL(1 year)
- lipids-HDL CHOLESTEROL(1 year)
- Rate of Insulin secretion(1 year)
- Rate of insulin resistance(1 year)
- lipids-LDL CHOLESTEROL(1 year)
- lipids-Triglycerides(1 year)
- blood pressure(1 year)
- urine microalbumin(1 year)
- HPA axis(1 year)
- systemic inflammation(1 year)
- omental and subcutaneous fat inflammation(8 weeks)