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The Effect of Folic Acid Administration in the Progression of Microalbuminuria

This study has been completed.
Sponsor:
Collaborator:
Laboratorios Valdecasas S.A.
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT00737126
First received: August 15, 2008
Last updated: August 18, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention
Diabetic Nephropathies
Hyperhomocysteinemia
 Drug: Folic acid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Folic Acid Administration Reduces the Progression of Microalbuminuria

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Change in albumin excretion rate [ Time Frame: Four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum homocysteine, thrombomodulin and von Willebrand factor. [ Time Frame: Four months. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Administration of an oral placebo pill
 Drug: Placebo
Administration of an oral placebo pill
Experimental: 2
Administration of oral folic acid
 Drug: Folic acid
Administration of a daily tablet containing 5 mg of folic acid for 4 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737126

Locations
Mexico
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Laboratorios Valdecasas S.A.
Investigators
Study Chair: Fernando J Lavalle, MD Departamento de Endocrinología del Hospital Universitario "José E. González"
  More Information

No publications provided

Responsible Party: Jesús Zacarías Villarreal Pérez, Departamento de Endocrinologia
ClinicalTrials.gov Identifier: NCT00737126     History of Changes
Other Study ID Numbers: Endo02
Study First Received: August 15, 2008
Last Updated: August 18, 2008
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Diabetic nephropathies
Hyperhomocysteinemia
Folic acid
Endothelial dysfunction

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Hyperhomocysteinemia
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013