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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

Page last updated: August 23, 2015

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