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Completed

NCT Number: NCT01456650

R230C and C230C Variants of ABCA1 and Glyburide Response

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion

Mexico City, 14000, Mexico

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in plasma fasting glucose

    Time frame: 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 outcomes

  1. HbA1c levels

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 21, 2011
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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