The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Hospital Universitario Dr. Jose E. Gonzalez

Status: Completed

Conditions: Diabetic Nephropathies; Hyperhomocysteinemia

Treatments: Drug: Folic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00737126

Endo02

Details and patient eligibility

About

The development of diabetic nephropathy has been linked to several genetic polymorphisms, including those related with homocysteine metabolism such as the methylenetetrahydrofolate reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated with hyperhomocysteinemia, which is a known independent risk factor for the development of endothelial dysfunction and cardiovascular disease.

In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The investigators performed this study to evaluate the prevalence of this polymorphism in type 2 diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial dysfunction and microalbuminuria before and after the administration of folic acid. We proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be reversed after the administration of folic acid.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus patients with 5 to 15 years of diagnosis
• Microalbuminuria (defined as a urinary albumin/creatinine ratio between 30 and 300 mg/g)
• A1c less than 9% in the last year

Exclusion criteria

• Acute diabetic complications
• A1c greater than 9% in the last year
• Acute infectious process
• Hepatic disease
• Thyroid disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Administration of an oral placebo pill

Treatment:

Drug: Placebo

2

Experimental group

Description:

Administration of oral folic acid

Treatment:

Drug: Folic acid