Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of participants with diabetes remission 1 year post surgery
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Diabetes Mellitus type 2
- •HBA1C < or= 9
- •eligible for bariatric surgery (after a hospital bariatric committee)
- •Advanced diarem>6
- •Signed an informed consent -
排除标准
- •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
研究组 & 干预措施
oxytocin
8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
干预措施: Oxytocin (Drug)
placebo
intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants with diabetes remission 1 year post surgery
时间窗: 1 year post surgery
HBA1C less then 6.5% without need for diabetes medication
Number of participants who improved their glycemic control
时间窗: 8 weeks
increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
weight loss
时间窗: 1 year
weight reduction - kg.
obesity
时间窗: 1 year
change in waist circumference
次要结局
- lipids-NON HDL CHOLESTEROL(1 year)
- lipids-HDL CHOLESTEROL(1 year)
- Rate of Insulin secretion(1 year)
- Rate of insulin resistance(1 year)
- lipids-LDL CHOLESTEROL(1 year)
- lipids-Triglycerides(1 year)
- blood pressure(1 year)
- urine microalbumin(1 year)
- HPA axis(1 year)
- systemic inflammation(1 year)
- omental and subcutaneous fat inflammation(8 weeks)