Bromocriptine Quick Release (QR) as Adjunct Therapy in Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI)
研究概览
简要总结
Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA) agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an exciting development, representing a novel mechanism for improving IR. BCQR has not been studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data support the proposed study of possible benefits of BCQR on insulin action, glycemic control, and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes will include fasting and postprandial glucose, glycemic variability, insulin dosing, hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes (T1D) of >1 year duration based on a clinical course consistent with T1D and rapid conversion to insulin requirement after diagnosis.
- •HbA1c 6.5-10% (adults) or any HbA1c up to 12% (pediatrics)
- •age 12-60 years of age
排除标准
- •Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia including cancer, heart failure, active or end stage liver disease, kidney disease (except microalbuminuria), inadequately treated thyroid disease, or rheumatologic disease;
- •Tobacco or marijuana use;
- •Regular or frequent oral steroid use;
- •Current use of insulin sensitizing medications, neuroleptics, ergot-related medications, or triptan medications for migraine,
- •Diagnosis or history of psychosis,
- •Diabetes of other cause such as Maturity Onset Diabetes of the Young or cystic fibrosis-related diabetes.
研究组 & 干预措施
Bromocriptine QR
4 weeks of investigational drug Bromocriptine QR
干预措施: Bromocriptine (Drug)
Placebo
4 weeks of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI)
时间窗: 4 weeks
At the end of each 4 week intervention period, we will measure the reactive hyperemia Index (RHI). The Reactive Hyperemia Index (RHI) measures increased bloodflow after vascular occlusion. Higher scores indicate lower CVD risk and a better outcome, Scores of less than 1.67 may be considered abnormal. Scores of 1.67 1.67-2.09 may be considered borderline, and scores of 2.10 or higher my be considered normal.
Brachial Artery Distensibility
时间窗: 4 weeks
At the end of each 4 week intervention period, we will measure the brachial artery distensibility as a measure of vascular stiffness by Dynapulse (%/mmHg). A larger number indicates less stiffness (ie greater compliance).
Insulin Dosing
时间窗: 4 weeks
At the end of each 4 week intervention period, we will measure the effect of BCQR on insulin dosing (units//kg/day)
Mean Glucose
时间窗: 4 weeks
At the end of each 4 week intervention period, we will measure the effect of Bromocriptine Quick Release on average glucose levels (mg/dl) by continuous glucose monitoring
次要结局
- Mean Glycemic Variability(4 weeks)
- Hypoglycemia Awareness(4 weeks)
- Heart Rate Variability (Adolescents)(4 weeks)
- Metabolic Markers - Insulin(4 weeks)
- Sleep Duration(4 weeks)
- Sleep Quality(4 weeks)
- Metabolic Markers-fatty Acids(4 weeks)
- Augmentation Index(4 weeks)
- Heart Rate Variability (Adults)(4 weeks)
- Metabolic Markers-glucose and Triglycerides(4 weeks)
- Metabolic Markers - GLP1(4 weeks)
- Metabolic Markers-glucagon(4 weeks)