The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Not Applicable

Completed

• Conditions: Diabetic Nephropathies; Hyperhomocysteinemia
• Interventions: Drug: Placebo; Drug: Folic acid

• Registration Number: NCT00737126
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Last Update Submitted: 2008-08-18
• Last Update Posted: 2008-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Administration of an oral placebo pill
2	Folic acid	Administration of oral folic acid

Primary Outcome Measures

Name	Time	Method
Change in albumin excretion rate	Four months

Secondary Outcome Measures

Name	Time	Method
Change in serum homocysteine, thrombomodulin and von Willebrand factor.	Four months.

Trial Locations

Locations (1)

Hospital Universitario "José E. González"; 🇲🇽 Monterrey, Nuevo León, Mexico