An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Progression of dysglicemia
研究概览
简要总结
Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.
详细描述
Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.
The investigators will enroll patients with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), not taking other hypoglycemic compounds. Patients will be randomized to take Reglicem® or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Reglicem® and placebo will be self-administered once a day, 1 tablet during the breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
- •Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)
排除标准
- •Patients with type 1 or type 2 diabetes mellitus
- •Patients with impaired hepatic function
- •Patient with impaired renal function
- •Patients with gastrointestinal disorders
- •Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
- •Patients with weight change of > 3 Kg during the preceding 3 months
- •Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
- •Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
- •Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.
结局指标
主要结局
Progression of dysglicemia
时间窗: 3 months
Oral glucose tolerance test
次要结局
未报告次要终点
研究者
Giuseppe Derosa
MD, PHd, FESC
University of Pavia