NCT00737126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
Last Updated

August 19, 2008

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

August 15, 2008

Last Update Submit

August 18, 2008

Conditions

Diabetic NephropathiesHyperhomocysteinemia

Keywords

Diabetic nephropathiesHyperhomocysteinemiaFolic acidEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in albumin excretion rate

    Four months

Secondary Outcomes (1)

  • Change in serum homocysteine, thrombomodulin and von Willebrand factor.

    Four months.

Study Arms (2)

1

PLACEBO COMPARATOR

Administration of an oral placebo pill

Drug: Placebo

2

EXPERIMENTAL

Administration of oral folic acid

Drug: Folic acid

Interventions

Folic acidDRUG

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

2
PlaceboDRUG

Administration of an oral placebo pill

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "José E. González"

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Diabetic NephropathiesHyperhomocysteinemia

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Fernando J Lavalle, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

January 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

August 19, 2008

Record last verified: 2008-08

Locations

ME(1)