Clinical trial NCT05207774: Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Official title: Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Diabetes
Bariatric Surgery
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2022-01-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of participants with diabetes remission 1 year post surgery
timeFrame: 1 year post surgery
measure: Number of participants who improved their glycemic control
timeFrame: 8 weeks
measure: weight loss
timeFrame: 8 weeks
measure: weight loss
timeFrame: 1 year
measure: obesity
timeFrame: 8 weeks
measure: obesity
timeFrame: 1 year
Secondary outcomes:
measure: Rate of Insulin secretion
timeFrame: 8 weeks
measure: Rate of Insulin secretion
timeFrame: 1 year
measure: Rate of insulin resistance
timeFrame: 8 weeks
measure: Rate of insulin resistance
timeFrame: 1 year
measure: lipids-LDL CHOLESTEROL
timeFrame: 8 weeks
measure: lipids-LDL CHOLESTEROL
timeFrame: 1 year
measure: lipids-HDL CHOLESTEROL
timeFrame: 8 weeks
measure: lipids-HDL CHOLESTEROL
timeFrame: 1 year
measure: lipids-NON HDL CHOLESTEROL
timeFrame: 8 weeks
measure: lipids-NON HDL CHOLESTEROL
timeFrame: 1 year
measure: lipids-Triglycerides
timeFrame: 8 weeks
measure: lipids-Triglycerides
timeFrame: 1 year
measure: blood pressure
timeFrame: 8 weeks
measure: blood pressure
timeFrame: 1 year
measure: urine microalbumin
timeFrame: 8 weeks
measure: urine microalbumin
timeFrame: 1 year
measure: HPA axis
timeFrame: 8 weeks
measure: HPA axis
timeFrame: 1 year
measure: HPA axis
timeFrame: 8 weeks
measure: HPA axis
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: systemic inflammation
timeFrame: 8 weeks
measure: systemic inflammation
timeFrame: 1 year
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
measure: omental and subcutaneous fat inflammation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Unuversity Medical Center
Study officials:
References: