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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05207774
Other study ID # SOR-0041-18-CTIL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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