Bariatric Surgery, Diabetes, Obesity
Conditions
Brief 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
Interventions
DRUGOxytocin
8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff
DRUGplacebo
8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff
Sponsors
Ben-Gurion University of the Negev
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with diabetes remission 1 year post surgery | 1 year post surgery | HBA1C less then 6.5% without need for diabetes medication |
| Number of participants who improved their glycemic control | 8 weeks | increase in Time in Range by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment |
| weight loss | 8 weeks | weight reduction - kg. |
| obesity | 8 weeks | change in waist circumference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipids-NON HDL CHOLESTEROL | 8 weeks | change in lipid profile: NON HDL cholesterol. triglycerides |
| lipids-Triglycerides | 8 weeks | change in lipid profile: triglycerides |
| blood pressure | 8 weeks | change in systolic and diastolic blood pressure |
| Rate of Insulin secretion | 8 weeks | Increase of insulin secretion after oxytocin administration |
| HPA axis | 8 weeks | change in cortisol |
| systemic inflammation | 8 weeks | changes of inflammation markers: hrCRP |
| omental and subcutaneous fat inflammation | 8 weeks | Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1 |
| urine microalbumin | 8 weeks | Change in microalbumin/creatinin |
| Rate of insulin resistance | 8 weeks | Increase of insulin sensitivity after oxytocin administration |
| lipids-LDL CHOLESTEROL | 8 weeks | change in lipid profile: LDL |
| lipids-HDL CHOLESTEROL | 8 weeks | change in lipid profile: HDL |
Countries
Israel
Outcome results
None listed