Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
试验速览
- 阶段
- 4 期
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- HOMA- IR
研究概览
简要总结
This study evaluates the effects of oral supplementation with curcumin on the insulin sensitivity in subjects with prediabetes. The half of participants will receive curcumin and bioperine in combination, while the other half receive placebo.
详细描述
The therapeutic strategies for prediabetes to this day are based on the change of habits, mainly food and exercise plans. It has been advice, in specific circumstances, to grant a pharmacological regimen.
Curcumin or Curcuma Longa ((1E,6E)21,7-bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione), is the main ingredient of the Hindu condiment, Turmeric, which is obtained from the Rhizome plant. In new studies, it has been documented that the oral consumption of curcumin (Curcuma longa) in pre-diabetic and diabetic patients has a positive effect as an antidiabetic agent thanks to its anti-inflammatory, antioxidant, antithrombotic, cardio and neuroprotective effects. In animal models, it has been shown that oral curcumin consumption is capable of increasing insulin sensitivity in liver, muscle and adipose tissue, increases glucose uptake in muscle and insulin secretion, which is reflected in the reduction of hyperglycemia, glycosylated hemoglobin, decrease of the homeostatic model assessment of insulin resistance (HOMA-IR) and decrease of serum lipids.
Curcumin has been included in the oriental diet since ancient times and is used in traditional medicine, which is why it is considered safe, since its consumption is approved by the FDA (Federal Drugs Administration). A 12g per day dose has shown no side effects in humans. Therefore, it is proposed that the consumption of curcumin in pre-diabetic patients can improve glucose tolerance and decrease insulin resistance parameters.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with age between 18 and 60 years old.
- •With prediabetes diagnosis, according to the American Diabetes Association :
- •Fasting serum glucose: 100-125 mg/dL
- •Glycosylated hemoglobin (HbA1c): 5.7-6.4%
- •Post-prandial glucose: 140-199 mg/dL after an oral dose of 75 g of glucose.
排除标准
- •Subjects with any type of diabetes.
- •Subjects with body mass index > 35 kg/m2
- •Pregnant Women.
- •Volunteers who ingest drugs that alter blood glucose levels, antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, fibrates, statins.
- •Subjects with serum creatinine > 2 mg/dL or in renal replacement therapy.
- •Subjects that normally consume food supplements.
- •Subjects with acute infections or with chronical diseases (cancer, rheumatoid arthritis, etc.).
研究组 & 干预措施
Curcumin and bioperine
This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months
干预措施: Curcumin (Drug)
Placebo
This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months
干预措施: Starch (Drug)
结局指标
主要结局
HOMA- IR
时间窗: 3 months
(Insulin µU/ml)(Glucose mg/dl)/405.
HOMA- Beta
时间窗: 3 months
(20)(FPI)/(FPG - 3.5)
Matsuda index
时间窗: 3 months
10,000/√\[(basal glucose)(basal insulin)\*(glucose)(insulin)\]
次要结局
- creatinine(6 weeks and 12 weeks)
- alkaline phosphatase(6 weeks and 12 weeks)
- lactic dehydrogenase(6 weeks and 12 weeks)
- height(6 weeks and 12 weeks)
- waist circumference(6 weeks and 12 weeks)
- hip circumference.(6 weeks and 12 weeks)
- insulin(6 weeks and 12 weeks)
- uric acid(6 weeks and 12 weeks)
- cholesterol(6 weeks and 12 weeks)
- LDL cholesterol(6 weeks and 12 weeks)
- urea(6 weeks and 12 weeks)
- alanine amino transferase(6 weeks and 12 weeks)
- glycosylated hemoglobin(6 weeks and 12 weeks)
- total bilirubin(6 weeks and 12 weeks)
- HDL cholesterol(6 weeks and 12 weeks)
- weight(6 weeks and 12 weeks)
- triglycerides(6 weeks and 12 weeks)
研究者
César Leonardo González Aguilar
Internal Medicine Resident
Hospital General de México Dr. Eduardo Liceaga