Effect of Phytoecdysterone Administration on Cytotoxicity, Genotoxicity and Metabolic Control in Subjects With Prediabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo
研究概览
简要总结
Prediabetes is the term used for people whose glucose levels do not meet the criteria for diabetes but are too high to be considered normal. This is defined by the presence of blood glucose between 100-125 mg / dL, values per glucose tolerance curve of 140-199mg / dL and/or HbA1c 5.7-6.4%. Prediabetes should not be considered as a clinical entity in itself, but as a risk factor for diabetes and cardiovascular disease (CVD). Prediabetes is associated with obesity (especially abdominal or visceral obesity), dyslipidemia with elevated triglycerides and/or low HDL cholesterol, and hypertension.
详细描述
Subjects with a diagnosis of prediabetes are included according to the criteria of the American Diabetes Association in its version 2019, between 30 and 60 years old residents of the city of Guadalajara, Jalisco, Mexico who come to clinical nutrition consultation in the University Hospital Fray Antonio Alcalde from the city of Guadalajara, Jalisco, Mexico.
The study design is a randomized, randomized clinical trial with a control group in two groups: an intervention group with ecdysterone 300mg every 24 hours for 12 weeks (approximately 90 days) and an approved placebo control group (magnesia stearate) ) at 300mg every 24 hours for 12 weeks (approximately 90 days).
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 (Care Provider, Outcomes Assessor)
盲法说明
Randomized double-blind clinical trial plus control group
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting Plasma Glucose between 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L)
- •Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
- •A1C 5.7-6.4% (39-47 mmol/mol).
- •Body Mass Index >25 kg/m2 or >23 kg/m2
- •Adults who have one or more of the following risk factors:
- •First-degree relative with diabetes
- •High-risk race/ethnicity
- •History of CVD
- •Blood Pressure <140/90 mmHg without therapy for hypertension
- •HDL cholesterol level <0.35 mg/dL (0.90 mmol/L) and/or a triglyceride level >0.250 mg/dL (2.82 mmol/L)
排除标准
- •1.- Pregnant women or lactic period 2- Patients with some other chronic degenerative disease like diabetes mellitus 2 with pharmacologic treatment.
- •3.- Hypertension 4.- Cancer, 5.- Hyperthyroidism 6.- Hypothyroidism 7.- Immunologic disease 8.- Kidney disease 9.- Hepatic disease 10.- Cardiovascular disease 11- Abaqus activity 12.-Alcoholic activity.
结局指标
主要结局
Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo
时间窗: 90 days
Glycosylated hemoglobin will be evaluated at baseline and day 90 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at day 90
Changes in the number of micronuclei after 90 days
时间窗: 90 days
The number of micronuclei will be evaluated at baseline and day 90 with Schmidt technique by giemsa/wright and the entered values reflect the number of micronuceli at day 90
Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo
时间窗: 90 days
The fasting glucose levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at day 90
次要结局
- Body Weight(90 days)
- Body Mass Index(90 days)
- Total Cholesterol(90 days)
- High Density Lipoprotein (c-HDL) levels(90 days)
- Waist Circumference(90 days)
- Low Density Lipoproteins (c-LDL) levels(90 days)
- Creatinine levels(90 days)
- Blood pressure(90 days)
- Triglycerides levels(90 days)
- Alanine aminotransferase (ALT) levels(90 days)
- Aspartate aminotransferase (AST) levels(90 days)
研究者
Ana Lilia Fletes Rayas
Reseach Professor Associated
University of Guadalajara