We Searched for the Effects of Calcium Channel Blocker Amlodipine on the Clinical and Laboratory Parameters of Diabetic Patients With Proteinuria.Phase 4NCT01738945
Effect of Calcium Channel Blocker on the Serum Fibrobalst Growth Factor-23 (FGF-23) Levels in Type-2 Diabetic Patients With Proteinuria Purpose
A Phase 4 study testing Amlodipine in people with We Searched for the Effects of Calcium Channel Blocker Amlodipine on the Clinical and Laboratory Parameters of Diabetic Patients With Proteinuria., run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most prevalent underlying disease of people in developed countries. A wide range of studies have been carried out, from various points of view, to understand the progress of renal dysfunction in diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- We Searched for the Effects of Calcium Channel Blocker Amlodipine on the Clinical and Laboratory Parameters of Diabetic Patients With Proteinuria.
- What is being tested?
- Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2008to May 2009
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage 1 patients
- Older than 18 years of age
- Type 2 Diabetic patients
- Proteinuria
Who cannot join
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most prevalent underlying disease of people in developed countries. A wide range of studies have been carried out, from various points of view, to understand the progress of renal dysfunction in diabetic nephropathy.
Fibroblast growth factor 23 (FGF-23) is a primary regulator of renal phosphate excretion. FGF23 is inversely associated with the GFR, a relationship underlying a fundamental mechanism for maintaining serum phosphate constancy during CKD progression. Such an adaptation may have deleterious trade-offs because, independently of serum phosphate, high FGF23 signals a high risk of death in ESRD patients. Some studies showed that there is relationship between FGF-23 levels and proteinuria in CKD patients.
Read more
There is no data about the effects of calcium channel blocker on FGF23 levels in diabetic patients with proteinuria. The aim of this study was to find out whether the beneficial effects of calcium channel blocker in diabetic proteinuria has any relation with the alteration of FGF-23 levels. The investigators searched for the effects of calcium channel blocker amlodipine on the clinical and laboratory parameters of diabetic patients with proteinuria.
The investigators registered the study 'The effect of renin angiotensin system Blockage (RAS), calcium channel blocker and combined drugs on TWEAK, PTX3 and FMD levels in Diabetic Proteinuric Patients with Hypertension' (ClinicalTrials.gov Identifier:NCT00921570). The investigators will use the samples of the some patients for this study. The investigators also registered the study 'FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric Patients' (ClinicalTrials.gov Identifier: NCT01703234). The investigators will combine these two registered studies (NCT00921570 and NCT01703234) in one study.
Read the detailed description
The patients who were non-obese (BMI<30kg/m2), non dyslipidemic (total cholesterol <200mg/dl, Triglyceride<150mg/dl), and free of cardiovascular events (negative medical history, negative ECG findings) were investigated for enrollment. CKD stage 1 patients older than 18 years of age and willing to participate to the study were screened. From the 231 patients with established type 2 diabetes mellitus, 126 had proteinuria and/or hypertension (24 h protein excretion 1-2 g/day, systolic blood pressures ≥140mmHg and/or diastolic blood pressures ≥ 90 mmHg, respectively). All cases were first referrals and at the time of the study all were off treatment. Patients with history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 61 screened patients 32 met the study criteria and were included in this study. The duration of proteinuria and diabetic nephropathy after initial diagnosis was not known.
The exclusion criteria were as follows: A)Nephrotic syndrome, B)coronary heart disease (patients with ischemic ST-T alterations and voltage criteria for LVH on electrocardiogram, and with history of revascularization or myocardial infarction), C) elevated liver enzymes (AST or ALT levels ≥ 40U/L) and D) renal failure (serum creatinine levels > 1.3 mg/dl). In order to evaluate the effect of calcium channel blocker on serum FGF-23 concentrations, patients with proteinuria were given an calcium channel blocker (Amlodipine 10 mg/day) for 12 weeks. The effect of calcium channel blocker on insulin sensitivity and proteinuria was also investigated.
After the intervention period, blood samples were obtained for assay of plasma PTX3 concentrations, HbA1c , and insulin resistance scores (HOMA-IR).
Urine samples were also collected over a 24-hour period to determine the degree of proteinuria.
- Being tested
- Amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
10 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine | Other | Amlodipine 10 mg/day for 12 weeks Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast Growth factor 23
Secondary outcomes (1)
Flow mediated dilatation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for We Searched for the Effects of Calcium Channel Blocker Amlodipine on the Clinical and Laboratory Parameters of Diabetic Patients With Proteinuria.Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Ilker Yilmaz, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738945
- Sponsor's protocol ID
- GATACCBFGF23
- Status last verified
- Feb 2008
- First submitted
- 28 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
Publications
Yilmaz MI, Sonmez A, Saglam M, Kurt YG, Unal HU, Karaman M, Gok M, Cetinkaya H, Eyileten T, Oguz Y, Vural A, Mallamaci F, Zoccali C. Ramipril lowers plasma FGF-23 in patients with diabetic nephropathy. Am J Nephrol. 2014;40(3):208-14. doi: 10.1159/000366169. Epub 2014 Oct 10.
PubMed 25324042
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Channel Blocker on the Serum Fibrobalst Growth Factor-23 (FGF-23) Levels in Type-2 Diabetic Patients With Proteinuria Purpose
- ClinicalTrials.gov ID
- NCT01738945
- Acronym / sponsor ID
- GATACCBFGF23
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Nov 2012 (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.
In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most prevalent underlying disease of people in developed countries. A wide range of studies have been carried out, from various points of view, to understand the progress of renal dysfunction in diabetic nephropathy.
Fibroblast growth factor 23 (FGF-23) is a primary regulator of renal phosphate excretion. FGF23 is inversely associated with the GFR, a relationship underlying a fundamental mechanism for maintaining serum phosphate constancy during CKD progression. Such an adaptation may have deleterious trade-offs because, independently of serum phosphate, high FGF23 signals a high risk of death in ESRD patients. Some studies showed that there is relationship between FGF-23 levels and proteinuria in CKD patients.
There is no data about the effects of calcium channel blocker on FGF23 levels in diabetic patients with proteinuria. The aim of this study was to find out whether the beneficial effects of calcium channel blocker in diabetic proteinuria has any relation with the alteration of FGF-23 levels. The investigators searched for the effects of calcium channel blocker amlodipine on the clinical and laboratory parameters of diabetic patients with proteinuria.
The investigators registered the study 'The effect of renin angiotensin system Blockage (RAS), calcium channel blocker and combined drugs on TWEAK, PTX3 and FMD levels in Diabetic Proteinuric Patients with Hypertension' (ClinicalTrials.gov Identifier:NCT00921570). The investigators will use the samples of the some patients for this study. The investigators also registered the study 'FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric Patients' (ClinicalTrials.gov Identifier: NCT01703234). The investigators will combine these two registered studies (NCT00921570 and NCT01703234) in one study.
Detailed description
The patients who were non-obese (BMI<30kg/m2), non dyslipidemic (total cholesterol <200mg/dl, Triglyceride<150mg/dl), and free of cardiovascular events (negative medical history, negative ECG findings) were investigated for enrollment. CKD stage 1 patients older than 18 years of age and willing to participate to the study were screened. From the 231 patients with established type 2 diabetes mellitus, 126 had proteinuria and/or hypertension (24 h protein excretion 1-2 g/day, systolic blood pressures ≥140mmHg and/or diastolic blood pressures ≥ 90 mmHg, respectively). All cases were first referrals and at the time of the study all were off treatment. Patients with history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 61 screened patients 32 met the study criteria and were included in this study. The duration of proteinuria and diabetic nephropathy after initial diagnosis was not known.
The exclusion criteria were as follows: A)Nephrotic syndrome, B)coronary heart disease (patients with ischemic ST-T alterations and voltage criteria for LVH on electrocardiogram, and with history of revascularization or myocardial infarction), C) elevated liver enzymes (AST or ALT levels ≥ 40U/L) and D) renal failure (serum creatinine levels > 1.3 mg/dl). In order to evaluate the effect of calcium channel blocker on serum FGF-23 concentrations, patients with proteinuria were given an calcium channel blocker (Amlodipine 10 mg/day) for 12 weeks. The effect of calcium channel blocker on insulin sensitivity and proteinuria was also investigated.
After the intervention period, blood samples were obtained for assay of plasma PTX3 concentrations, HbA1c , and insulin resistance scores (HOMA-IR).
Urine samples were also collected over a 24-hour period to determine the degree of proteinuria.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amlodipine | Other | Drug: AmlodipineAmlodipine 10 mg/day for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD stage 1 patients
- Older than 18 years of age
- Type 2 Diabetic patients
- Proteinuria
Key exclusion criteria (3 listed)
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
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 |
|---|---|---|
| Amlodipine10 mg/day for 12 weeks | Drug | Amlodipine |
Primary outcome
Fibroblast Growth factor 23
1 secondary outcome
Flow mediated dilatation
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 30 Nov 2012.
- Derived from this study: PubMed 25324042Yilmaz MI, Sonmez A, Saglam M, Kurt YG, Unal HU, Karaman M, Gok M, Cetinkaya H, Eyileten T, Oguz Y, Vural A, Mallamaci F, Zoccali C. Ramipril lowers plasma FGF-23 in patients with diabetic nephropathy. Am J Nephrol. 2014;40(3):208-14. doi: 10.1159/000366169. Epub 2014 Oct 10.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine in people with We Searched for the Effects of Calcium Channel Blocker Amlodipine on the Clinical and Laboratory Parameters of Diabetic Patients With Proteinuria., run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 30 Nov 2012. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fibroblast Growth factor 23. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738945, which also lists 1 linked publication.
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 30 Nov 2012.