Trials / Unknown
UnknownNCT05207774
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Soroka University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin | 8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff |
| DRUG | placebo | 8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff |
Timeline
- Start date
- 2020-01-09
- Primary completion
- 2023-08-30
- Completion
- 2025-08-30
- First posted
- 2022-01-26
- Last updated
- 2022-01-26
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT05207774. Inclusion in this directory is not an endorsement.