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| Name | Class |
|---|---|
| University of Lausanne Hospitals | OTHER |
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This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.
Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.
Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Placebo Comparator | placebo-controlled, randomized, cross-over study |
|
| Metformine | Placebo Comparator | placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Pioglitazone on Renal Hemodynamics | At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF | 2008 |
| Effects of Pioglitazone on Sodium and Lithium Clearances | At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances | 2007 |
| Effects of Pioglitazone on 24h Blood Pressure Control | 24 hour blood pressure measurements were performed after each treatment/diet phase | march 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Pioglitazone on Salt Sensitivity | 2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoinette Pechere-Bertschi, MD | University Hospital, Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pechère-Bertschi Antoinette | Geneva | Canton of Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21752899 | Derived | Zanchi A, Pechere-Bertschi A, Burnier M, Bonny O. Effects of pioglitazone on renal calcium excretion. J Clin Endocrinol Metab. 2011 Sep;96(9):E1482-5. doi: 10.1210/jc.2011-0373. Epub 2011 Jul 13. | |
| 20414637 | Derived | Zanchi A, Maillard M, Jornayvaz FR, Vinciguerra M, Deleaval P, Nussberger J, Burnier M, Pechere-Bertschi A. Effects of the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone on renal and hormonal responses to salt in diabetic and hypertensive individuals. Diabetologia. 2010 Aug;53(8):1568-75. doi: 10.1007/s00125-010-1756-2. Epub 2010 Apr 23. |
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Each subject was randomised to receive either pioglitazone or placebo for 6 weeks, with a 2 week wash-out period between the two treatment phases. Randomisation of the sequences of placebo and active treatment periods were performed by a doctor having no contact with participants and clinicians.
Sixteen subjects were examined, 8 with a diagnosis of type 2 diabetes (DM2) and 8 with a diagnosis of systemic hypertension (HTN). The participants were recruited by hospital placards detailing the study, and through ambulatory care centers in Lausanne and Geneva.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone Low Salt/High Salt | a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase |
| FG001 | Placebo Low Salt/High Salt | a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone Low Salt/High Salt | a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase |
| BG001 | Placebo Low Salt/High Salt |
| 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 |
| 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 | Effects of Pioglitazone on Renal Hemodynamics | At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF | Posted | Jun 2010 | Mean | Standard Error | ml/min/1.73m2 | 2008 |
|
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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 | Pioglitazone Low Salt/High Salt | a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase |
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The sample size may seem small but the cross over design of the study increased the statistical power. Each of 16 individuals was examined 4 times after the 4 different phases (pioglitazone-low salt, and high salt, placebo low salt and high salt).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zanchi Anne, MD | University Hospital Geneva and Lausanne, Switzerland | 0041213140775 | azanchidel@hotmail.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Metformin | Drug | placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance |
|
|
a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Effects of Pioglitazone on Sodium and Lithium Clearances | At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances | Posted | Jun 2010 | Mean | Standard Error | ml/min | 2007 |
|
|
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| Primary | Effects of Pioglitazone on 24h Blood Pressure Control | 24 hour blood pressure measurements were performed after each treatment/diet phase | Posted | Jul 2010 | Mean | Standard Error | mmHg | march 2009 |
|
|
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| Secondary | Effects of Pioglitazone on Salt Sensitivity | Not Posted | Jun 2010 | Mean | Standard Error | mmHg | 2009 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo Low Salt/High Salt | a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase | 0 | 0 | 0 | 0 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |