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The Effect of Folic Acid Administration in the Progression of Microalbuminuria

NCT ID: NCT00737126

Last Updated: 2008-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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Conditions

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Diabetic Nephropathies Hyperhomocysteinemia

Keywords

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Diabetic nephropathies Hyperhomocysteinemia Folic acid Endothelial dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Administration of an oral placebo pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of an oral placebo pill

2

Administration of oral folic acid

Group Type EXPERIMENTAL

Folic acid

Intervention Type DRUG

Administration of a daily tablet containing 5 mg of folic acid for 4 months.

Interventions

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Folic acid

Administration of a daily tablet containing 5 mg of folic acid for 4 months.

Intervention Type DRUG

Placebo

Administration of an oral placebo pill

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Valdecasas S.A.

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role lead

Responsible Party

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Departamento de Endocrinologia

Principal Investigators

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Fernando J Lavalle, MD

Role: STUDY_CHAIR

Departamento de Endocrinología del Hospital Universitario "José E. González"

Locations

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Hospital Universitario "José E. González"

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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Endo02

Identifier Type: -

Identifier Source: org_study_id