EFFECT OF CHROMIUM PICOLINATE ON GLUCOSE CONTROL IN TYPE 2 DIABETIC PATIENTS

吡啶甲酸铬对 2 型糖尿病患者血糖控制的影响

• 批准号: 6264689
• 负责人: William T. Cefalu
• 金额: $ 3.29万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264689
• 关键词: blood glucose; chromium; clinical research; diabetes mellitus therapy; dietary supplements; glucose clamp technique; glucose tolerance test; human subject; human therapy evaluation; insulin sensitivity /resistance; noninsulin dependent diabetes mellitus; nutrition related tag; oral administration; sulfonylurea

Chromium picolinate has been shown in pilot studies to favorably improve insulin action as demonstrated in obese, non-diabetic individuals. If insulin sensitivity is improved, it could be used as a supplement in the treatment of diabetes. Yet the precise mechanism by which chromium may improve carbohydrate metabolism is not yet known. It may be argued that there is a direct effect, or it may be an indirect effect through changes in body composition. The purpose of the above mentioned study is to compare the efficacy of chromium supplementation vs placebo on glycemic control, insulin sensitivity, and body composition in Type 2 diabetic subjects. The study design was a double blinded placebo controlled trial. All subjects will have a one month drug washout at the end of which a euglycemic clamp, CT scan, glycemic indices and oral glucose tolerance test will be obtained. Patients are admitted the night prior to clamping for insulin infusion to maintain glycemia prior to the clamp. After the determination of insulin sensitivity, all subjects will then be treated for three months with an oral sulfonulurea and all parameters repeated. At the end of the sulfonylurea phase, patients will be continued to receive the oral medication with 1000ug chromium picolinate or placebo. Subjects will be evaluated for 6 months during which glycemic parameters, insulin, dietary intake, and compliance will be assessed. At the end of the study, all study parameters will be repeated. The hypothesis to be tested is that chromium supplementation will improve insulin resistance and this will be reflected in improved glycemic parameters for the Type 2 diabetic patient. If the hypothesis proves correct, future studies aimed at defining the specific mechanism would be planned.

初步研究表明，吡啶甲酸铬可有效改善肥胖、非糖尿病个体的胰岛素作用。 如果胰岛素敏感性得到改善，则可以作为治疗糖尿病的补充剂。 然而铬改善碳水化合物代谢的确切机制尚不清楚。 有人可能认为存在直接影响，也可能通过身体成分的变化产生间接影响。 上述研究的目的是比较铬补充剂与安慰剂对 2 型糖尿病受试者的血糖控制、胰岛素敏感性和身体成分的功效。 该研究设计是双盲安慰剂对照试验。所有受试者将进行一个月的药物清除，最后将获得正常血糖钳夹、CT 扫描、血糖指数和口服葡萄糖耐量测试。 患者在钳夹前一天晚上入院进行胰岛素输注，以维持钳夹前的血糖。 确定胰岛素敏感性后，所有受试者将接受口服磺脲类药物治疗三个月，并重复所有参数。 在磺酰脲类药物阶段结束时，患者将继续接受口服药物1000ug吡啶甲酸铬或安慰剂。 受试者将接受为期 6 个月的评估，在此期间将评估血糖参数、胰岛素、饮食摄入量和依从性。 研究结束时，将重复所有研究参数。待检验的假设是，补充铬将改善胰岛素抵抗，这将反映在 2 型糖尿病患者血糖参数的改善上。 如果该假设被证明是正确的，未来将计划进行旨在定义具体机制的研究。