Status:
COMPLETED
R230C and C230C Variants of ABCA1 and Glyburide Response
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
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...
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01456650
Start Date
March 1 2011
End Date
December 1 2012
Last Update
January 15 2014
Active Locations (1)
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1
Instituto Nacional de Ciencias Medicas y Nutricion
Mexico City, Mexico City, Mexico, 14000