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ObesityNCT05207774

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

A study testing Oxytocin in people with Obesity and Diabetes, run by Soroka University Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Diabetes, Bariatric Surgery
What is being tested?
Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteIsrael
Study dates
9 Jan 2020to 30 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 -

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Soroka Unuversity Medical Center

    Beersheba, 8410101

Other trials in Israel

About this study

Official title: 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

Being tested
Oxytocin, placebo
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff

  • placeboDrug

    8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff

Study groups in NCT05207774
Study groupRoleWhat they receive
oxytocinExperimental8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Receives: Drug: Oxytocin
placeboPlacebo comparatorintranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with diabetes remission 1 year post surgery

    HBA1C less then 6.5% without need for diabetes medication

    Measured: 1 year post surgery

  2. 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

    Measured: 8 weeks

  3. weight loss

    weight reduction - kg.

    Measured: 8 weeks

  4. weight loss

    weight reduction - kg.

    Measured: 1 year

  5. obesity

    change in waist circumference

    Measured: 8 weeks

  6. obesity

    change in waist circumference

    Measured: 1 year

Secondary outcomes (99)

  1. Rate of Insulin secretion

    Increase of insulin secretion after oxytocin administration

    Measured: 8 weeks

  2. Rate of Insulin secretion

    Increase of insulin secretion after oxytocin administration

    Measured: 1 year

  3. Rate of insulin resistance

    Increase of insulin sensitivity after oxytocin administration

    Measured: 8 weeks

  4. Rate of insulin resistance

    Increase of insulin sensitivity after oxytocin administration

    Measured: 1 year

  5. lipids-LDL CHOLESTEROL

    change in lipid profile: LDL

    Measured: 8 weeks

  6. lipids-LDL CHOLESTEROL

    change in lipid profile: LDL

    Measured: 1 year

  7. lipids-HDL CHOLESTEROL

    change in lipid profile: HDL

    Measured: 8 weeks

  8. lipids-HDL CHOLESTEROL

    change in lipid profile: HDL

    Measured: 1 year

  9. lipids-NON HDL CHOLESTEROL

    change in lipid profile: NON HDL cholesterol. triglycerides

    Measured: 8 weeks

  10. lipids-NON HDL CHOLESTEROL

    change in lipid profile: NON HDL cholesterol. triglycerides

    Measured: 1 year

  11. lipids-Triglycerides

    change in lipid profile: triglycerides

    Measured: 8 weeks

  12. lipids-Triglycerides

    change in lipid profile: triglycerides

    Measured: 1 year

  13. blood pressure

    change in systolic and diastolic blood pressure

    Measured: 8 weeks

  14. blood pressure

    change in systolic and diastolic blood pressure

    Measured: 1 year

  15. urine microalbumin

    Change in microalbumin/creatinin

    Measured: 8 weeks

  16. urine microalbumin

    Change in microalbumin/creatinin

    Measured: 1 year

  17. HPA axis

    change in cortisol

    Measured: 8 weeks

  18. HPA axis

    change in cortisol

    Measured: 1 year

  19. HPA axis

    change in ACTH

    Measured: 8 weeks

  20. HPA axis

    change in ACTH

    Measured: 1 year

  21. systemic inflammation

    changes of inflammation markers: hrCRP

    Measured: 8 weeks

  22. systemic inflammation

    changes of inflammation markers: hrCRP

    Measured: 1 year

  23. systemic inflammation

    changes of inflammation markers: IL-6

    Measured: 8 weeks

  24. systemic inflammation

    changes of inflammation markers: IL-6

    Measured: 1 year

  25. systemic inflammation

    changes of inflammation markers: TNFα

    Measured: 8 weeks

  26. systemic inflammation

    changes of inflammation markers: TNFα

    Measured: 1 year

  27. systemic inflammation

    changes of inflammation markers: IL-1α

    Measured: 8 weeks

  28. systemic inflammation

    changes of inflammation markers: IL-1α

    Measured: 1 year

  29. systemic inflammation

    changes of inflammation markers: IL-1RA

    Measured: 8 weeks

  30. systemic inflammation

    changes of inflammation markers: IL-1RA

    Measured: 1 year

  31. systemic inflammation

    changes of inflammation markers: IL-17

    Measured: 8 weeks

  32. systemic inflammation

    changes of inflammation markers: IL-17

    Measured: 1 year

  33. systemic inflammation

    changes of inflammation markers: IL-21

    Measured: 8 weeks

  34. systemic inflammation

    changes of inflammation markers: IL-21

    Measured: 1 year

  35. systemic inflammation

    changes of inflammation markers: adiponectin

    Measured: 8 weeks

  36. systemic inflammation

    changes of inflammation markers: adiponectin

    Measured: 1 year

  37. systemic inflammation

    changes of inflammation markers: leptin

    Measured: 8 weeks

  38. systemic inflammation

    changes of inflammation markers:leptin

    Measured: 1 year

  39. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1

    Measured: 8 weeks

  40. 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

    Measured: 8 weeks

  41. 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

    Measured: 8 weeks

  42. 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

    Measured: 8 weeks

  43. 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

    Measured: 8 weeks

  44. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL

    Measured: 8 weeks

  45. 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

    Measured: 8 weeks

  46. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5

    Measured: 8 weeks

  47. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1

    Measured: 8 weeks

  48. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.

    Measured: 8 weeks

  49. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,

    Measured: 8 weeks

  50. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8

    Measured: 8 weeks

  51. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68

    Measured: 8 weeks

  52. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1

    Measured: 8 weeks

  53. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1

    Measured: 8 weeks

  54. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,

    Measured: 8 weeks

  55. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2

    Measured: 8 weeks

  56. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53

    Measured: 8 weeks

  57. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1

    Measured: 8 weeks

  58. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1

    Measured: 8 weeks

  59. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT

    Measured: 8 weeks

  60. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1

    Measured: 8 weeks

  61. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1

    Measured: 8 weeks

  62. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF

    Measured: 8 weeks

  63. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36

    Measured: 8 weeks

  64. 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

    Measured: 8 weeks

  65. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN

    Measured: 8 weeks

  66. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C

    Measured: 8 weeks

  67. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206

    Measured: 8 weeks

  68. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163

    Measured: 8 weeks

  69. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209

    Measured: 8 weeks

  70. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF

    Measured: 8 weeks

  71. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD

    Measured: 8 weeks

  72. 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

    Measured: 8 weeks

  73. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB

    Measured: 8 weeks

  74. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA

    Measured: 8 weeks

  75. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT

    Measured: 8 weeks

  76. omental and subcutaneous fat inflammation

    Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1

    Measured: 8 weeks

  77. 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

    Measured: 8 weeks

  78. 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

    Measured: 8 weeks

  79. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: E2F1

    Measured: 8 weeks

  80. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: ASK1

    Measured: 8 weeks

  81. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: p-62

    Measured: 8 weeks

  82. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: TRAL

    Measured: 8 weeks

  83. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: TL-1A,

    Measured: 8 weeks

  84. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: PEPD

    Measured: 8 weeks

  85. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: PAI-1

    Measured: 8 weeks

  86. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: family of ATGs

    Measured: 8 weeks

  87. omental and subcutaneous fat inflammation

    Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin

    Measured: 8 weeks

  88. omental and subcutaneous fat inflammation

    ELISA: adiponectin

    Measured: 8 weeks

  89. omental and subcutaneous fat inflammation

    ELISA: leptin

    Measured: 8 weeks

  90. omental and subcutaneous fat inflammation

    ELISA: TNF

    Measured: 8 weeks

  91. omental and subcutaneous fat inflammation

    ELISA: IL-6

    Measured: 8 weeks

  92. omental and subcutaneous fat inflammation

    histological studies :Adipocyte size distribution.

    Measured: 8 weeks

  93. omental and subcutaneous fat inflammation

    histological studies : CD68 staining

    Measured: 8 weeks

  94. omental and subcutaneous fat inflammation

    histological studies :,c-kit staining

    Measured: 8 weeks

  95. 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

    Measured: 8 weeks

  96. 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

    Measured: 8 weeks

  97. 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

    Measured: 8 weeks

  98. 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

    Measured: 8 weeks

  99. 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).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start9 Jan 2020
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion30 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207774
Sponsor's protocol ID
SOR-0041-18-CTIL
Status last verified
Nov 2021
First submitted
23 Oct 2019
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin in people with Obesity and Diabetes, run by Soroka University Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with diabetes remission 1 year post surgery (time frame: 1 year post surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.

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