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

Not Applicable

Active, not recruiting

• Conditions: Obesity; Diabetes; Bariatric Surgery
• Interventions: Drug: Oxytocin; Drug: placebo

• Registration Number: NCT05207774
• Lead Sponsor: Soroka University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study Start: 2020-01-09
• Status Verified: 2021-11
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Primary Completion: 2023-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	Oxytocin	8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
placebo	placebo	intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks

Primary Outcome Measures

Name	Time	Method
Number of participants with diabetes remission 1 year post surgery	1 year post surgery	HBA1C less then 6.5% without need for diabetes medication
Number of participants who improved their glycemic control	8 weeks	increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
weight loss	1 year	weight reduction - kg.
obesity	1 year	change in waist circumference

Secondary Outcome Measures

Name	Time	Method
lipids-NON HDL CHOLESTEROL	1 year	change in lipid profile: NON HDL cholesterol. triglycerides
Rate of Insulin secretion	1 year	Increase of insulin secretion after oxytocin administration
Rate of insulin resistance	1 year	Increase of insulin sensitivity after oxytocin administration
lipids-LDL CHOLESTEROL	1 year	change in lipid profile: LDL
lipids-HDL CHOLESTEROL	1 year	change in lipid profile: HDL
lipids-Triglycerides	1 year	change in lipid profile: triglycerides
blood pressure	1 year	change in systolic and diastolic blood pressure
urine microalbumin	1 year	Change in microalbumin/creatinin
HPA axis	1 year	change in ACTH
systemic inflammation	1 year	changes of inflammation markers:leptin
omental and subcutaneous fat inflammation	8 weeks	Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: CTRP6/12/2 (ng/ml).

Trial Locations

Locations (1)

Soroka Unuversity Medical Center; 🇮🇱 Beer Sheva, Israel