R230C and C230C Variants of ABCA1 and Glyburide Response

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Glyburide

• Registration Number: NCT01456650
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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%

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glyburide	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HbA1c levels	20 weeks

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion; 🇲🇽 Mexico City, DF, Mexico