Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, ABCA1 alleles, Glyburide
Brief summary
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.
Detailed description
Specific objectives: 1. 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 2. 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%
Interventions
DRUGGlyburide
Patients in which the fasting glucose persisted above the treatment goal ( fasting plasma glucose above 126 mg/dl) will receive glyburide. The dose of the medication will be adjusted based on the result of blood glucose using the following table: Fasting glucose 126 to 140 mg/dl: 2.5 mg/day (half tablet in the morning) 141 to 180 mg/dl: 5 mg/day (a tablet in the morning) 181 220 mg/dl: 7.5 mg/day (a tablet in the morning and half tablet per night) 221 to 250 mg/dl: 10 mg/day (a tablet in the morning) and a tablet in the evening.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma fasting glucose | 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 |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c levels | 20 weeks |
Countries
Mexico
Outcome results
None listed