Clinical Trial: The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Folic Acid Administration Reduces the Progression of Microalbuminuria

Brief Summary:

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.

Detailed Summary:
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Current Primary Outcome: Change in albumin excretion rate [ Time Frame: Four months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in serum homocysteine, thrombomodulin and von Willebrand factor. [ Time Frame: Four months. ]

Original Secondary Outcome: Same as current

Information By: Hospital Universitario Dr. Jose E. Gonzalez

Dates:
Date Received: August 15, 2008
Date Started: January 2004
Date Completion:
Last Updated: August 18, 2008
Last Verified: August 2008