R230C and C230C Variants of ABCA1 and Glyburide Response

NCT01456650 | Completed Phase 4

• 1 other identifier: INNSZ-ABCA1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; ABCA1 alleles; Glyburide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• HbA1c levels

  20 weeks

Study Arms (1)

Glyburide

EXPERIMENTAL

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.

Drug: Glyburide

Interventions

Glyburide DRUG

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.

Glyburide

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion

Mexico City, Mexico City, 14000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 23273975 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Carlos A Aguilar-Salinas, MD

  Instituto Nacional de Ciencias Medicas y Nutricion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Head of the Department of Endocrinology and Metabolism

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 21, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

ME (1)