Diabetic Nephropathies Clinical Trial
Official title:
Folic Acid Administration Reduces the Progression of Microalbuminuria
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2005 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario "José E. González" | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez | Laboratorios Valdecasas S.A. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in albumin excretion rate | Four months | No | |
Secondary | Change in serum homocysteine, thrombomodulin and von Willebrand factor. | Four months. | No |
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