An interventional study of Oxytocin and placebo in Obesity, Diabetes and Bariatric Surgery, sponsored by Soroka University Medical Center. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 3 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Drug: Oxytocin
intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Drug: placebo
8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff
8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff
Number of participants with diabetes remission 1 year post surgery
HBA1C less then 6.5% without need for diabetes medication
Time frame: 1 year post surgery
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
Time frame: 8 weeks
weight loss
weight reduction - kg.
Time frame: 8 weeks
weight loss
weight reduction - kg.
Time frame: 1 year
obesity
change in waist circumference
Time frame: 8 weeks
obesity
change in waist circumference
Time frame: 1 year
Rate of Insulin secretion
Increase of insulin secretion after oxytocin administration
Time frame: 8 weeks
Rate of Insulin secretion
Increase of insulin secretion after oxytocin administration
Time frame: 1 year
Rate of insulin resistance
Increase of insulin sensitivity after oxytocin administration
Time frame: 8 weeks
Rate of insulin resistance
Increase of insulin sensitivity after oxytocin administration
Time frame: 1 year
lipids-LDL CHOLESTEROL
change in lipid profile: LDL
Time frame: 8 weeks
lipids-LDL CHOLESTEROL
change in lipid profile: LDL
Time frame: 1 year
lipids-HDL CHOLESTEROL
change in lipid profile: HDL
Time frame: 8 weeks
lipids-HDL CHOLESTEROL
change in lipid profile: HDL
Time frame: 1 year
lipids-NON HDL CHOLESTEROL
change in lipid profile: NON HDL cholesterol. triglycerides
Time frame: 8 weeks
lipids-NON HDL CHOLESTEROL
change in lipid profile: NON HDL cholesterol. triglycerides
Time frame: 1 year
lipids-Triglycerides
change in lipid profile: triglycerides
Time frame: 8 weeks
lipids-Triglycerides
change in lipid profile: triglycerides
Time frame: 1 year
blood pressure
change in systolic and diastolic blood pressure
Time frame: 8 weeks
blood pressure
change in systolic and diastolic blood pressure
Time frame: 1 year
urine microalbumin
Change in microalbumin/creatinin
Time frame: 8 weeks
urine microalbumin
Change in microalbumin/creatinin
Time frame: 1 year
HPA axis
change in cortisol
Time frame: 8 weeks
HPA axis
change in cortisol
Time frame: 1 year
HPA axis
change in ACTH
Time frame: 8 weeks
HPA axis
change in ACTH
Time frame: 1 year
systemic inflammation
changes of inflammation markers: hrCRP
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: hrCRP
Time frame: 1 year
systemic inflammation
changes of inflammation markers: IL-6
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: IL-6
Time frame: 1 year
systemic inflammation
changes of inflammation markers: TNFα
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: TNFα
Time frame: 1 year
systemic inflammation
changes of inflammation markers: IL-1α
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: IL-1α
Time frame: 1 year
systemic inflammation
changes of inflammation markers: IL-1RA
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: IL-1RA
Time frame: 1 year
systemic inflammation
changes of inflammation markers: IL-17
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: IL-17
Time frame: 1 year
systemic inflammation
changes of inflammation markers: IL-21
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: IL-21
Time frame: 1 year
systemic inflammation
changes of inflammation markers: adiponectin
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers: adiponectin
Time frame: 1 year
systemic inflammation
changes of inflammation markers: leptin
Time frame: 8 weeks
systemic inflammation
changes of inflammation markers:leptin
Time frame: 1 year
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL
Time frame: 8 weeks
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
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36
Time frame: 8 weeks
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
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD
Time frame: 8 weeks
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
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: E2F1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: ASK1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: p-62
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: TRAL
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: TL-1A,
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: PEPD
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: PAI-1
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: family of ATGs
Time frame: 8 weeks
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin
Time frame: 8 weeks
omental and subcutaneous fat inflammation
ELISA: adiponectin
Time frame: 8 weeks
omental and subcutaneous fat inflammation
ELISA: leptin
Time frame: 8 weeks
omental and subcutaneous fat inflammation
ELISA: TNF
Time frame: 8 weeks
omental and subcutaneous fat inflammation
ELISA: IL-6
Time frame: 8 weeks
omental and subcutaneous fat inflammation
histological studies :Adipocyte size distribution.
Time frame: 8 weeks
omental and subcutaneous fat inflammation
histological studies : CD68 staining
Time frame: 8 weeks
omental and subcutaneous fat inflammation
histological studies :,c-kit staining
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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).
Time frame: 8 weeks
Plan to share: Yes
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Soroka University Medical Center