Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
This study aims to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp).
详细描述
Drop-outs will be replaced; data will be used as much as can be. Subjects will undergo a Screening visit to assess eligibility and will then be scheduled to undergo 2 outpatient US treatment visits.
On day three subjects first undergo a third ultrasound session and then will either undergo Oral Glucose Tolerance Test (OGTT) with carbon13 (13C-glucose) tracer administration and subsequent NMR spectroscopy OR if enrolled into the HEC study arm will undergo euglycemic clamp testing. Following these procedures there will be an approximately two-week follow-up observational Period (with CGM). A two-week washout period will be followed by another cycle of the same procedures of either OGTT/NMR or HEC study, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic (T2D) subjects must be aged 18-80 and must be able to provide written informed consent
- •All subjects must have had T2D for at least 3 months prior to study enrollment. All subjects must be either on diet and exercise or oral antidiabetic agents alone, not on insulin or any form of insulin or GLP-1 receptor agonists.
- •Subjects must demonstrate:
- •A past medical history of abnormal glucose control and carry a diagnosis of T2D according to current ADA criteria:
- •A fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher, or
- •A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or
- •A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis or
- •A hemoglobin A1c (HbA1c) level of 6.5% or higher.
- •Be willing to carry a continuous glucose monitor for at least 10 days.
- •Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.
排除标准
- •BMI >40kg/m
- •Untreated proliferative retinopathy
- •Creatinine clearance < 60 ml/min/1.73 m
- •Serum creatinine ≥1.5 mg/dL
- •Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- •Active infection including hepatitis C, hepatitis B, HIV,
- •Any history of Active alcohol abuse
- •History of non-adherence to prescribed regimens
- •Baseline Hgb < 10.5 g/dL in females, or < 13 g/dL in males
- •History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
- •Co-existing cardiac disease with active medication titration. Patients on stable meds without active cardiac complications permitted.
- •Liver function tests outside of 3xUL of normal range
- •GI disorders potentially interfering with the ability to absorb oral medications and h/o upper GI surgery that might have changed anatomy in the target areas.
- •Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.
结局指标
主要结局
Insulin Sensitivity
时间窗: Measured during HE clamp.
Insulin Sensitivity calculated as Glucose disposal rate / insulin ratio during steady state (M/I) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)
Glucose metabolic clearance rate
时间窗: Measured during HE clamp.
Glucose metabolic clearance rate during steady state (MCR) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)
Glucose disposal rate
时间窗: Measured during HE clamp.
Glucose disposal rate during steady state (M) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)
次要结局
- Low blood glucose index (LBGI)(1 week)
- Glycogen synthesis rates(during glucose tolerance testing (for 180 minutes).)
- Change from baseline in blood glucose (BG) time spent in defined glucose ranges(1 week)
- Absolute glycogen level(during glucose tolerance testing (for 180 minutes).)
- Average daily glucose(1 week)
- High blood glucose index (HBGI)(1 week)