Diabetic NephropathiesNCT00737126
The Effect of Folic Acid Administration in the Progression of Microalbuminuria
A study testing Folic acid in people with Diabetic Nephropathies and Hyperhomocysteinemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies, Hyperhomocysteinemia
- What is being tested?
- Folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2004to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute diabetic complications
- A1c greater than 9% in the last year
- Acute infectious process
- Hepatic disease
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "José E. González"
Monterrey, Nuevo León, 64460
About this study
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.
- Conditions
- Diabetic Nephropathies, Hyperhomocysteinemia
- Being tested
- Folic acid, Placebo
- Keywords
- Diabetic nephropathies, Hyperhomocysteinemia, Folic acid, Endothelial dysfunction
- Medical subject headings
- Diabetic Nephropathies, Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDrug
Administration of a daily tablet containing 5 mg of folic acid for 4 months.
PlaceboDrug
Administration of an oral placebo pill
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Administration of an oral placebo pill Receives: Drug: Placebo |
| 2 | Experimental | Administration of oral folic acid Receives: Drug: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in albumin excretion rate
Measured: Four months
Secondary outcomes (1)
Change in serum homocysteine, thrombomodulin and von Willebrand factor.
Measured: Four months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorios Valdecasas S.A.
- Investigators
- Fernando J Lavalle, MD, Study chair, Departamento de Endocrinología del Hospital Universitario "José E. González"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737126
- Sponsor's protocol ID
- Endo02
- Status last verified
- Aug 2008
- First submitted
- 15 Aug 2008
- Last updated
- 19 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid Administration Reduces the Progression of Microalbuminuria
- ClinicalTrials.gov ID
- NCT00737126
- Acronym / sponsor ID
- Endo02
- Conditions
- Diabetic Nephropathies, Hyperhomocysteinemia
- Keywords
- Diabetic nephropathies, Hyperhomocysteinemia, Folic acid, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Collaborators
- Laboratorios Valdecasas S.A.
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboAdministration of an oral placebo pill |
| 2 | Experimental | Drug: Folic acidAdministration of oral folic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Acute diabetic complications
- A1c greater than 9% in the last year
- Acute infectious process
- Hepatic disease
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acidAdministration of a daily tablet containing 5 mg of folic acid for 4 months. | Drug | 2 |
| PlaceboAdministration of an oral placebo pill | Drug | 1 |
Primary outcome
Change in albumin excretion rate
Time frame: Four months
1 secondary outcome
Change in serum homocysteine, thrombomodulin and von Willebrand factor.
Time frame: Four months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando J Lavalle, MD study chair
Departamento de Endocrinología del Hospital Universitario "José E. González"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid in people with Diabetic Nephropathies and Hyperhomocysteinemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in albumin excretion rate (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2008.