The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 主要终点
- Change in hemoglobin A1c
研究概览
简要总结
The study is an initial non-blinded, non-placebo controlled trial to determine the efficacy of L-glutamine in lowering blood sugar in patients with diabetes mellitus type II without sickle cell anemia.
详细描述
The protocol will consist of starting patients on 15 g of L glutamine twice daily by mouth. This is the same dose that is used to treat patient with sickle cell anemia. They will be given this medication for a total of 3 months. Their other medications will remain the same. At the conclusion of the 3 months, the patients will be taken off of the glutamine and will continue their other medications. The investigators will monitor the patients an additional 3 months (6 months after the initiation of the study) off the L-glutamine. In this manner, the investigators will have a washout period. The outcome will be a comparison of the results before the initiation of the L-glutamine, to the results after treatment, and after the washout.
Data analysis will consist of comparing the patient's fasting glucose and hemoglobin A1c values. The investigators will also check the levels of fructosamine. This is a standard test that is done in any clinical laboratory. To help determine the mechanism for the L-glutamine effect, the investigators will also measure the complete blood count, chemistry panel, hepatic function panel, urine micro-albumin, patients' weight, and waist circumference. The investigators will use the Student t-test for statistical analysis. Significance will be tested at the 0.05 level.
The investigators will collect demographic information on the patients in the study. Age, sex, duration of diabetes, smoking history, and race will be noted. The investigators will use regression analysis to determine whether these factors have any effects on the observed results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed diagnosis of diabetes mellitus type II
- •Patient of Straub Medical Center, Internal Medicine Clinic
排除标准
- •Renal and liver impairment ( GFR less than 40)
- •Transaminitis (elevation of AST of ALT more than 2 fold)
- •Patient with sickle cell anemia
研究组 & 干预措施
L-glutamine
Treatment with L-glutamine for 3 months.
干预措施: L-glutamine (Drug)
No L-glutamine
No L-glutamine for 3 months.
干预措施: No L-glutamine (Other)
结局指标
主要结局
Change in hemoglobin A1c
时间窗: 3 months and 6 months
Change in hemoglobin A1c
Change in fasting glucose
时间窗: 3 months and 6 months
Change in fasting glucose
次要结局
- Change in weight(3 months and 6 months)
- Change in waist circumference(3 months and 6 months)
- Change in hepatic function(3 months and 6 months)
- Change in fructosamine(3 months and 6 months)
- Change in complete blood count(3 months and 6 months)
- Change in microablbumin(3 months and 6 months)
- Change in blood chemistry(3 months and 6 months)
研究者
Charles R Zerez, PhD, MD
Internal Medicine Physician
Hawaii Pacific Health