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

What Was Tested

This registered not phased trial tested Oxytocin.

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults with diabetes undergoing bariatric 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.

It had two arms (groups): oxytocin (experimental) and placebo (placebo comparator).

Intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 3 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diabetes Mellitus type 2. HBA1C \< or= 9. Eligible for bariatric surgery (after a hospital bariatric committee). Signed an informed consent -.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: HBA1C above 9; prior bariatric surgery in the past 6 years; secondary diabetes.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2020-01-09 with completion listed for 2023-08-30.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with diabetes remission 1 year post surgery (time frame: 1 year post surgery). weight loss (time frame: 8 weeks). weight loss (time frame: 1 year).

It also tracked 99 secondary outcomes, for example Rate of Insulin secretion, Rate of Insulin secretion, Rate of insulin resistance, Rate of insulin resistance, lipids-LDL CHOLESTEROL and lipids-LDL CHOLESTEROL.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 3 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.