R230C and C230C Variants of ABCA1 and Glyburide Response
Information source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Glyburide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Official(s) and/or principal investigator(s): Carlos A Aguilar-Salinas, MD, Principal Investigator, Affiliation: Instituto Nacional de Ciencias Medicas y Nutricion
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Change in plasma fasting glucose
Secondary outcome: HbA1c levels
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%
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, DF 14000, Mexico
Additional Information
Starting date: March 2011
Last updated: January 14, 2014
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