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R230C and C230C Variants of ABCA1 and Glyburide Response

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Glyburide

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, ABCA1 alleles, Glyburide

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto Nacional de Ciencias Medicas y Nutricion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glyburide

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c levels

Full Information

NCT ID

NCT01456650

First Posted

October 19, 2011

Last Updated

January 14, 2014

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

1. Study Identification

Unique Protocol Identification Number

NCT01456650

Brief Title

R230C and C230C Variants of ABCA1 and Glyburide Response

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 Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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 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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 diabetes, ABCA1 alleles, Glyburide

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glyburide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Glyburide

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in plasma fasting glucose

Description

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

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

HbA1c levels

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos A Aguilar-Salinas, MD

Organizational Affiliation

Instituto Nacional de Ciencias Medicas y Nutricion

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Nacional de Ciencias Medicas y Nutricion

City

Mexico City

State/Province

ZIP/Postal Code

14000

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

23273975

Citation

Aguilar-Salinas CA, Munoz-Hernandez LL, Cobos-Bonilla M, Ramirez-Marquez MR, Ordonez-Sanchez ML, Mehta R, Medina-Santillan R, Tusie-Luna MT. The R230C variant of the ATP binding cassette protein A1 (ABCA1) gene is associated with a decreased response to glyburide therapy in patients with type 2 diabetes mellitus. Metabolism. 2013 May;62(5):638-41. doi: 10.1016/j.metabol.2012.11.006. Epub 2012 Dec 27.

Results Reference

derived

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R230C and C230C Variants of ABCA1 and Glyburide Response

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