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Objective:
To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.
Background:
Diabetic nephropathy is a world wide public health concern of increasing proportions. It has become the most common single cause of end-stage renal disease in the United States and in Europe. Previous studies have already found agents modifying the renin-angiotensin-system (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These agents are likely to exert multiple effects in the kidney. One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics.
In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone. In that study, rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a reduction of urinary albumin excretion. The observed effects are potentially important in the context of renal protection, provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).
Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosiglitazone | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone | Drug | 4 mg tablets, bid, 12 months |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proteinuria | at baseline and after 6 and 12 mo of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Hemodynamic | at baseline and after 6 and 12 mo of tretament | |
| Renal Function | at abseline and after 6 and 12 mo | |
| Adverse Event |
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Inclusion Criteria:
type 2 diabetes mellitus -age between 40 and 75 years -well controlled HbA1c (< 7.5%) -chronic renal failure (creatinin clearance between 70 and 30 mL/(min x 1.73 m²) according to the Cockroft equation) -proteinuria > 300 mg / 24 hours
Exclusion Criteria:
type 1 diabetes -poorly controlled type 2 diabetes (HbA1c > 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring) -elevation of ALT, AST or GGT more than 2.5 fold the upper normal value -CHF (more than grade 1 of NYHA) -uncontrolled hypertension -malignant tumorous disorder -hyper- or hypothyroidism -pregnant women -nursing women
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| Name | Affiliation | Role |
|---|---|---|
| Frank Pistrosch, M.D. | Nephrology, Department of Medicine, University hospital Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Dresden | Dresden | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22723267 | Derived | Pistrosch F, Passauer J, Herbrig K, Schwanebeck U, Gross P, Bornstein SR. Effect of thiazolidinedione treatment on proteinuria and renal hemodynamic in type 2 diabetic patients with overt nephropathy. Horm Metab Res. 2012 Nov;44(12):914-8. doi: 10.1055/s-0032-1314836. Epub 2012 Jun 21. |
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2 enrolled patients were excluded: one withdrew infromed consent, one developed anaphylactic reaction to sinistrin (used for renal function test)
recruitment at medical clinic and outpatient department
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosiglitazone | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
2 tablets per day |
|
| every month or at occurence |
| HbA1c | at baseline and after 6 and 12 mo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosiglitazone | |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proteinuria | per protocol | Posted | Mean | Standard Error | g/24hr | at baseline and after 6 and 12 mo of treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Renal Hemodynamic | Not Posted | at baseline and after 6 and 12 mo of tretament | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renal Function | Not Posted | at abseline and after 6 and 12 mo | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Event | Not Posted | every month or at occurence | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c | Not Posted | at baseline and after 6 and 12 mo |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosiglitazone | 1 | 14 | 12 | 14 | |||
| EG001 | Placebo | 2 | 14 | 9 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sleep apnoe | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| atrial fibrillation with congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peripheral edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| anemia new or worsening | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| hypoglycemia | Endocrine disorders | Systematic Assessment |
| ||
| painful calf or foot | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| hypotension | Vascular disorders | Systematic Assessment |
| ||
| common cold | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Pistrosch | University Hospital "Carl Gustav Carus", Dresden | 0049 351 4400580 | frank.pistrosch@uniklinikum-dresden.de |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011507 | Proteinuria |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Male |
|
| 12 mo |
|