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

NCT05207774 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-01-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ben-Gurion University of the Negev

    collaborator OTHER

  • Soroka University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2023-08-30
Completion
2025-08-30

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207774 on ClinicalTrials.gov