The Effects of Organic Chromium Supplementation on Clinical Parameters of the Metabolic Syndrome, in Patients With Type 2 Diabetes Mellitus. A Randomised, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the effect of Baker's yeast treatment on glycemicic control and insulin resistance when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus
研究概览
简要总结
The purpose of this study is to determine whether chromium (yeast), is effective in improving glycaemic control and insulin resistance.
详细描述
Setting:
Patients meeting the inclusion and not the exclusion criteria will be sent a letter containing information about the study and that they will be called within 2 weeks by one of the investigators. If the patient agrees to come for a fist visit he or she will be invited for a first visit to come to the general practice of Heerde.
Informed Consent:
During the telephone call and the first visit, patients will be able to ask any question. When the patient is properly informed and gives written informed consent the patient will be included for this study. Specific items such as duration of the study, the frequency of follow-up visits, and the voluntary nature of participation will be discussed prior to obtaining informed consent. Also, because of potential reproductive toxicity (no reports are known of developmental toxicity studies on Cr3+ compounds given orally), we will advice patients to take contraceptive precautions (33).
Stop criteria:
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes with haemoglobin A1c level between 7 and 8.5% at the last visit
- •treated with oral blood glucose lowering therapy, which has not been changed for the last three months.
排除标准
- •pregnant women; women trying to become pregnant
- •patients with a serum creatinine concentration over 150 micromol/l in men and 120 micromol/l in women, Cockcroft < 50 ml/min
- •hepatic enzyme levels (ALAT) over 90 U/l (2 x upper limit)
- •patients known with allergy or intolerance for yeast
- •patients currently taking chromium supplements
- •patients treated with insulin.
结局指标
主要结局
To determine the effect of Baker's yeast treatment on glycemicic control and insulin resistance when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus
次要结局
- To determine the effect of Baker's yeast treatment on serum lipids, blood pressure, body fat percentage and BMI when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus