Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary outcome measure used for sample size evaluations is the (before and after) change in the rate of glucose disposal during infusion of insulin (Rd, in mg of glucose/kg lean body mass/minute)
研究概览
简要总结
This research is to investigate the nutritional supplement chromium picolinate. A large number of people use chromium picolinate from health food stores to improve the function of the hormone insulin. The investigators are testing how effective this supplement is and are also monitoring its safety. In patients with diabetes, chromium has been shown to increase sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to insulin, the investigators are studying obese individuals with documented insulin resistance. The investigators would like to know if chromium is also effective in treating the insulin resistance associated with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years;
- •a BMI greater or equal to 30; AND
- •an abnormal 2 hour postprandial glucose (greater than 140 mg/dl but less than 200 mg/dl) following 75 grams of a glucose load.
排除标准
- •positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
- •diagnosis of cancer;
- •acute illness of any sort, however, patients may be enrolled once they are stable;
- •hemoglobin less than 11.0 g/dl or hemodynamically unstable;
- •creatinine greater than or equal to 1.5 mg/dl;
- •liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
- •use of certain medications within the past month (e.g., glucocorticoids).
- •untreated hypertension (systolic BP > 150 mmHG, diastolic BP>IOO mmHG);
- •patients with diabetes mellitus;
- •hypogonadism;
- •abnormal thyroid function (serum T4 < 4 or > 12; TSH < 0.35 or > 5.5) (12) any chronic liver or kidney disease; OR
- •polycystic ovarian syndrome.
结局指标
主要结局
The primary outcome measure used for sample size evaluations is the (before and after) change in the rate of glucose disposal during infusion of insulin (Rd, in mg of glucose/kg lean body mass/minute)
时间窗: 8 weeks
次要结局
未报告次要终点