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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05207774
• Other study ID #: SOR-0041-18-CTIL
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: August 30, 2025

Study information

• Verified date: November 2021
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes
• Diabetes Mellitus
• Obesity

Intervention

Drug:
• Oxytocin
8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff
• placebo
8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff

Locations

Country	Name	City	State
Israel	Soroka Unuversity Medical Center	Beer Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with diabetes remission 1 year post surgery	HBA1C less then 6.5% without need for diabetes medication	1 year post surgery
Primary	Number of participants who improved their glycemic control	increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment	8 weeks
Primary	weight loss	weight reduction - kg.	8 weeks
Primary	weight loss	weight reduction - kg.	1 year
Primary	obesity	change in waist circumference	8 weeks
Primary	obesity	change in waist circumference	1 year
Secondary	Rate of Insulin secretion	Increase of insulin secretion after oxytocin administration	8 weeks
Secondary	Rate of Insulin secretion	Increase of insulin secretion after oxytocin administration	1 year
Secondary	Rate of insulin resistance	Increase of insulin sensitivity after oxytocin administration	8 weeks
Secondary	Rate of insulin resistance	Increase of insulin sensitivity after oxytocin administration	1 year
Secondary	lipids-LDL CHOLESTEROL	change in lipid profile: LDL	8 weeks
Secondary	lipids-LDL CHOLESTEROL	change in lipid profile: LDL	1 year
Secondary	lipids-HDL CHOLESTEROL	change in lipid profile: HDL	8 weeks
Secondary	lipids-HDL CHOLESTEROL	change in lipid profile: HDL	1 year
Secondary	lipids-NON HDL CHOLESTEROL	change in lipid profile: NON HDL cholesterol. triglycerides	8 weeks
Secondary	lipids-NON HDL CHOLESTEROL	change in lipid profile: NON HDL cholesterol. triglycerides	1 year
Secondary	lipids-Triglycerides	change in lipid profile: triglycerides	8 weeks
Secondary	lipids-Triglycerides	change in lipid profile: triglycerides	1 year
Secondary	blood pressure	change in systolic and diastolic blood pressure	8 weeks
Secondary	blood pressure	change in systolic and diastolic blood pressure	1 year
Secondary	urine microalbumin	Change in microalbumin/creatinin	8 weeks
Secondary	urine microalbumin	Change in microalbumin/creatinin	1 year
Secondary	HPA axis	change in cortisol	8 weeks
Secondary	HPA axis	change in cortisol	1 year
Secondary	HPA axis	change in ACTH	8 weeks
Secondary	HPA axis	change in ACTH	1 year
Secondary	systemic inflammation	changes of inflammation markers: hrCRP	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: hrCRP	1 year
Secondary	systemic inflammation	changes of inflammation markers: IL-6	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: IL-6	1 year
Secondary	systemic inflammation	changes of inflammation markers: TNFa	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: TNFa	1 year
Secondary	systemic inflammation	changes of inflammation markers: IL-1a	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: IL-1a	1 year
Secondary	systemic inflammation	changes of inflammation markers: IL-1RA	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: IL-1RA	1 year
Secondary	systemic inflammation	changes of inflammation markers: IL-17	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: IL-17	1 year
Secondary	systemic inflammation	changes of inflammation markers: IL-21	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: IL-21	1 year
Secondary	systemic inflammation	changes of inflammation markers: adiponectin	8 weeks
Secondary	systemic inflammation	changes of inflammation markers: adiponectin	1 year
Secondary	systemic inflammation	changes of inflammation markers: leptin	8 weeks
Secondary	systemic inflammation	changes of inflammation markers:leptin	1 year
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ASK1/2	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: LC3-II	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: family of ATGs	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:p-62	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TL-1A	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: IL-6	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PAI-1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control-PGK1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control PPIA	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: E2F1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: ASK1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: p-62	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: TRAL	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: TL-1A,	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: PEPD	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: PAI-1	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: family of ATGs	8 weeks
Secondary	omental and subcutaneous fat inflammation	Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin	8 weeks
Secondary	omental and subcutaneous fat inflammation	ELISA: adiponectin	8 weeks
Secondary	omental and subcutaneous fat inflammation	ELISA: leptin	8 weeks
Secondary	omental and subcutaneous fat inflammation	ELISA: TNF	8 weeks
Secondary	omental and subcutaneous fat inflammation	ELISA: IL-6	8 weeks
Secondary	omental and subcutaneous fat inflammation	histological studies :Adipocyte size distribution.	8 weeks
Secondary	omental and subcutaneous fat inflammation	histological studies : CD68 staining	8 weeks
Secondary	omental and subcutaneous fat inflammation	histological studies :,c-kit staining	8 weeks
Secondary	omental and subcutaneous fat inflammation	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: adiponectin	8 weeks
Secondary	omental and subcutaneous fat inflammation	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: leptin	8 weeks
Secondary	omental and subcutaneous fat inflammation	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: TNF	8 weeks
Secondary	omental and subcutaneous fat inflammation	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: IL-6	8 weeks
Secondary	omental and subcutaneous fat inflammation	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).	8 weeks