Effect of Calcium Channel Blocker on the Serum Fibrobalst Growth Factor-23 (FGF-23) Levels in Type-2 Diabetic Patients With Proteinuria Purpose

NCT01738945 | Completed Phase 4

• 1 other identifier: GATACCBFGF23
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

We Searched for the Effects of Calcium Channel Blocker Amlodipine on the Clinical and Laboratory Parameters of Diabetic Patients With Proteinuria.

Outcome Measures

Primary Outcomes (1)

• Fibroblast Growth factor 23

Secondary Outcomes (1)

• Flow mediated dilatation

Study Arms (1)

Amlodipine

OTHER

Amlodipine 10 mg/day for 12 weeks

Drug: Amlodipine

Interventions

Amlodipine DRUG

10 mg/day for 12 weeks

Amlodipine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD stage 1 patients
• Older than 18 years of age
• Type 2 Diabetic patients
• Proteinuria

You may not qualify if:

• History of coronary artery disease
• Smokers
• Taking statins or renin-angiotensin blockers

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25324042 DERIVED

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesoor

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 30, 2012

Record last verified: 2008-02

Locations

TU (1)