R230C and C230C Variants of ABCA1 and Glyburide Response

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456650
• Other study ID #: INNSZ-ABCA1
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2011
• Last updated: January 14, 2014
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Glyburide
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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma fasting glucose	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	20 weeks	No
Secondary	HbA1c levels		20 weeks	No