R230C and C230C Variants of ABCA1 and Glyburide Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Aguilar, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01456650
First received: October 19, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Glyburide
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Change in plasma fasting glucose [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.


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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456650

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion
Mexico City, DF, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Carlos A Aguilar-Salinas, MD Instituto Nacional de Ciencias Medicas y Nutricion
  More Information

No publications provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Aguilar, Vice Head of the Department of Endocrinology and Metabolism, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01456650     History of Changes
Other Study ID Numbers: INNSZ-ABCA1
Study First Received: October 19, 2011
Last Updated: January 14, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Type 2 diabetes
ABCA1 alleles
Glyburide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014