Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
January 12, 2022 updated by: Soroka University Medical Center
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beer Sheva, Israel, 8410101
- Soroka Unuversity Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: oxytocin
8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
|
8 weeks intranasal oxytocin 24 units per day.
8 units prior each meal.
4units/0.1 ml per puff
|
|
PLACEBO_COMPARATOR: placebo
intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
|
8 weeks intranasal placebo 0.6 ml per day. .
0.1 ml per puff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with diabetes remission 1 year post surgery
Time Frame: 1 year post surgery
|
HBA1C less then 6.5% without need for diabetes medication
|
1 year post surgery
|
|
Number of participants who improved their glycemic control
Time Frame: 8 weeks
|
increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
|
8 weeks
|
|
weight loss
Time Frame: 8 weeks
|
weight reduction - kg.
|
8 weeks
|
|
weight loss
Time Frame: 1 year
|
weight reduction - kg.
|
1 year
|
|
obesity
Time Frame: 8 weeks
|
change in waist circumference
|
8 weeks
|
|
obesity
Time Frame: 1 year
|
change in waist circumference
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Insulin secretion
Time Frame: 8 weeks
|
Increase of insulin secretion after oxytocin administration
|
8 weeks
|
|
Rate of Insulin secretion
Time Frame: 1 year
|
Increase of insulin secretion after oxytocin administration
|
1 year
|
|
Rate of insulin resistance
Time Frame: 8 weeks
|
Increase of insulin sensitivity after oxytocin administration
|
8 weeks
|
|
Rate of insulin resistance
Time Frame: 1 year
|
Increase of insulin sensitivity after oxytocin administration
|
1 year
|
|
lipids-LDL CHOLESTEROL
Time Frame: 8 weeks
|
change in lipid profile: LDL
|
8 weeks
|
|
lipids-LDL CHOLESTEROL
Time Frame: 1 year
|
change in lipid profile: LDL
|
1 year
|
|
lipids-HDL CHOLESTEROL
Time Frame: 8 weeks
|
change in lipid profile: HDL
|
8 weeks
|
|
lipids-HDL CHOLESTEROL
Time Frame: 1 year
|
change in lipid profile: HDL
|
1 year
|
|
lipids-NON HDL CHOLESTEROL
Time Frame: 8 weeks
|
change in lipid profile: NON HDL cholesterol.
triglycerides
|
8 weeks
|
|
lipids-NON HDL CHOLESTEROL
Time Frame: 1 year
|
change in lipid profile: NON HDL cholesterol.
triglycerides
|
1 year
|
|
lipids-Triglycerides
Time Frame: 8 weeks
|
change in lipid profile: triglycerides
|
8 weeks
|
|
lipids-Triglycerides
Time Frame: 1 year
|
change in lipid profile: triglycerides
|
1 year
|
|
blood pressure
Time Frame: 8 weeks
|
change in systolic and diastolic blood pressure
|
8 weeks
|
|
blood pressure
Time Frame: 1 year
|
change in systolic and diastolic blood pressure
|
1 year
|
|
urine microalbumin
Time Frame: 8 weeks
|
Change in microalbumin/creatinin
|
8 weeks
|
|
urine microalbumin
Time Frame: 1 year
|
Change in microalbumin/creatinin
|
1 year
|
|
HPA axis
Time Frame: 8 weeks
|
change in cortisol
|
8 weeks
|
|
HPA axis
Time Frame: 1 year
|
change in cortisol
|
1 year
|
|
HPA axis
Time Frame: 8 weeks
|
change in ACTH
|
8 weeks
|
|
HPA axis
Time Frame: 1 year
|
change in ACTH
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: hrCRP
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: hrCRP
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: IL-6
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: IL-6
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: TNFα
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: TNFα
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: IL-1α
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: IL-1α
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: IL-1RA
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: IL-1RA
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: IL-17
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: IL-17
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: IL-21
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: IL-21
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: adiponectin
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers: adiponectin
|
1 year
|
|
systemic inflammation
Time Frame: 8 weeks
|
changes of inflammation markers: leptin
|
8 weeks
|
|
systemic inflammation
Time Frame: 1 year
|
changes of inflammation markers:leptin
|
1 year
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ASK1/2
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: LC3-II
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: family of ATGs
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:p-62
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TL-1A
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: IL-6
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PAI-1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control-PGK1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control PPIA
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: E2F1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: ASK1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: p-62
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: TRAL
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: TL-1A,
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: PEPD
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: PAI-1
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: family of ATGs
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
ELISA: adiponectin
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
ELISA: leptin
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
ELISA: TNF
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
ELISA: IL-6
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
histological studies :Adipocyte size distribution.
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
histological studies : CD68 staining
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
|
histological studies :,c-kit staining
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 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: adiponectin
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 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: leptin
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 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: TNF
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 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: IL-6
|
8 weeks
|
|
omental and subcutaneous fat inflammation
Time Frame: 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).
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 9, 2020
Primary Completion (ANTICIPATED)
August 30, 2023
Study Completion (ANTICIPATED)
August 30, 2025
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
January 12, 2022
First Posted (ACTUAL)
January 26, 2022
Study Record Updates
Last Update Posted (ACTUAL)
January 26, 2022
Last Update Submitted That Met QC Criteria
January 12, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOR-0041-18-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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