Effect of the R230C Variant of the ATP-binding Cassette Transporter A1 (ABCA1) Gene on the Response to Treatment With Glibenclamide in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in plasma fasting glucose
研究概览
简要总结
The objective of the study is to know if the R230C and C230C variants of the ATP-binding cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect compared to the wild type allele (R230R) in patients with type 2 diabetes.
详细描述
Specific objectives:
- In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following continuous variables:
- Fasting glucose
- Percentage reduction
- Hemoglobin A1c,
- Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol
- Weight
- In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following binomial variables:
- Number of cases that reach fasting plasma glucose lower than 110 mg/dl
- Number of cases that reach an HbA1c less than 7%
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 20 to 79 years
- •Body mass index >18 and 39.9 ≤
- •Men or women
- •Mexicans mestizos.
- •Moderate hyperglycemia (126 to 250 mg/dl and HbA1c levels between 7 and 10%) despite being treated with a dietary program in combination or not with metformin (2 g/d).
排除标准
- •Patients with chronic complications of diabetes: ischemic heart disease, stroke, proliferative retinopathy or blindness, albuminuria, chronic diarrhea, gastroparesis, non-traumatic amputation of lower limbs.
- •Patients with any monogenic syndrome, obesity, diabetes or hypoalphalipoproteinemia
- •Patients with acquired diseases that produce secondarily obesity or diabetes.
- •Treatment with anorexigenics or accelerate weight loss at the time of the selection.
- •Cardiovascular event in the 6 months prior to study entry.
- •Steroids, chemotherapy, immunosuppressive or radiotherapy.
- •Infections or concurrent acute diseases.
- •Catabolic diseases such as cancer or AIDS
- •Pregnancy
研究组 & 干预措施
Glyburide
Patients in which the fasting glucose persisted above the treatment goal (fasting glucose <126 mg/dl) after a 4 week diet period will receive glyburide. The dose of the medication will be adjusted based on the results of fasting glucose values. At each visit patients will return the leftover tablets; counts of the tablets will be the method for measuring the adherence to treatment. The medical study participants who decided to doses of glibenclamide will not know the allele of ABCA1 gene under study.
干预措施: Glyburide (Drug)
结局指标
主要结局
Change in plasma fasting glucose
时间窗: 20 weeks
The effects of the alleles under study on the glucose lowering effect of glyburide will be assessed in 20 week study. Diet and exercise will be controlled per protocol
次要结局
- HbA1c levels(20 weeks)
研究者
Carlos Aguilar
Vice Head of the Department of Endocrinology and Metabolism
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran