- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01090752
Renal and Hormonal Effects of Pioglitazone
Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Geneva, Schweiz, 1211
- Pechère-Bertschi Antoinette
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type II Diabetes
- Hypertension
Exclusion Criteria:
- Cardiac or renal diseases
- Anaemia
- Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Pioglitazone
placebo-controlled, randomized, cross-over study
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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
Andre navne:
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
Andre navne:
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Placebo komparator: Metformine
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
|
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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Effects of Pioglitazone on Renal Hemodynamics
Tidsramme: 2008
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At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF
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2008
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Effects of Pioglitazone on Sodium and Lithium Clearances
Tidsramme: 2007
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At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances
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2007
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Effects of Pioglitazone on 24h Blood Pressure Control
Tidsramme: march 2009
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24 hour blood pressure measurements were performed after each treatment/diet phase
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march 2009
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Effects of Pioglitazone on Salt Sensitivity
Tidsramme: 2009
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2009
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Antoinette Pechere-Bertschi, MD, University Hospital, Geneva
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FDAAA
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West Virginia UniversityRekruttering
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National Cancer Institute (NCI)Afsluttet
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