DiabetesPhase 4NCT01090752

Renal and Hormonal Effects of Pioglitazone

A Phase 4 study testing Pioglitazone and Metformin in people with Diabetes and Hypertension, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes, Hypertension
What is being tested?: Pioglitazone and Metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteSwitzerland
Study dates: Oct 2005to Oct 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Type II Diabetes
Hypertension

Who cannot join

Cardiac or renal diseases
Anaemia
Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Pechère-Bertschi Antoinette
Geneva, Canton of Geneva, 1211

Other trials in Switzerland

About this study

Official title: Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects

This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Read the detailed description

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.

Conditions: Diabetes, Hypertension
Being tested: Pioglitazone, Metformin
Keywords: diabetes, blood pressure, pioglitazone, sodium, insulin resistance, renal function, sodium, pioglitazone
Medical subject headings: Diabetes Mellitus, Hypertension, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PioglitazoneDrug
Also called Actos
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
MetforminDrug
Also called Glucophage, Glumetza, Fortamet, Riomet
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

Study groups in NCT01090752
Study group	Role	What they receive
Pioglitazone	Placebo comparator	placebo-controlled, randomized, cross-over study Receives: Drug: Pioglitazone; Drug: Metformin
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 Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 2007
Effects of Pioglitazone on 24h Blood Pressure Control
24 hour blood pressure measurements were performed after each treatment/diet phase
Measured: march 2009

Secondary outcomes (1)

Effects of Pioglitazone on Salt Sensitivity
Measured: 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Oct 2007

First posted22 Mar 2010 (estimated)
Study startOct 2005
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by University Hospital, GenevaThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01090752
Sponsor's protocol ID: FDAAA
Status last verified: Jan 2009
First submitted: 19 Mar 2010
Last updated: 8 Apr 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21752899
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.
PubMed 20414637

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects
ClinicalTrials.gov ID: NCT01090752
Acronym / sponsor ID: FDAAA
Conditions: Diabetes, Hypertension
Keywords: diabetes, blood pressure, pioglitazone, sodium, insulin resistance, renal function, sodium, pioglitazone
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University Hospital, GenevaUniversity, hospital or other
Collaborators: University of Lausanne Hospitals
Study start: Oct 2005
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 22 Mar 2010 (estimated)
Results: Posted 8 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pioglitazone	Placebo comparator	Drug: Pioglitazone, Drug: Metforminplacebo-controlled, randomized, cross-over study
Metformine	Placebo comparator	Drug: Metforminplacebo-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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Type II Diabetes
Hypertension

Key exclusion criteria (3 listed)

Cardiac or renal diseases
Anaemia
Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.

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
PioglitazoneAlso: Actosplacebo-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	Drug	Pioglitazone
MetforminAlso: Glucophage, Glumetza, Fortamet, Riometplacebo-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	Drug	Metformine, Pioglitazone

Primary outcome

Effects of Pioglitazone on Renal Hemodynamics
Time frame: 2008
At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF
Effects of Pioglitazone on Sodium and Lithium Clearances
Time frame: 2007
At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances
Effects of Pioglitazone on 24h Blood Pressure Control
Time frame: march 2009
24 hour blood pressure measurements were performed after each treatment/diet phase

1 secondary outcome

Effects of Pioglitazone on Salt Sensitivity
Time frame: 2009

Results and safety

Results posted to the registry on 8 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone Low Salt/High Salt	8	8
Placebo Low Salt/High Salt	8	8

Primary outcome: Effects of Pioglitazone on Renal Hemodynamics

Time frame: 2008. Mean (Standard Error). Unit: ml/min/1.73m2

Measure	Pioglitazone Low Salt/High Salt n = 16	Placebo Low Salt/High Salt n = 16
Value	68.0 (4.4)	62.4 (5.0)

Primary outcome: Effects of Pioglitazone on Sodium and Lithium Clearances

Time frame: 2007. Mean (Standard Error). Unit: ml/min

Measure	Pioglitazone Low Salt/High Salt n = 16	Placebo Low Salt/High Salt n = 16
Value	1.05 (0.10)	1.18 (0.13)

Primary outcome: Effects of Pioglitazone on 24h Blood Pressure Control

Time frame: march 2009. Mean (Standard Error). Unit: mmHg

Measure	Pioglitazone Low Salt/High Salt n = 16	Placebo Low Salt/High Salt n = 16
Value	128 (5)	129 (5)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone Low Salt/High Salt	0 of 0	0 of 0	Not reported
Placebo Low Salt/High Salt	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21752899Zanchi 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.
Derived from this study: PubMed 20414637Zanchi 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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Type 2 Diabetes
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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.

Antoinette Pechere-Bertschi, MD study director

University Hospital, Geneva

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 Pioglitazone and Metformin in people with Diabetes and Hypertension, run by University Hospital, Geneva at 1 site in Switzerland.

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 2 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 8 Apr 2010. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effects of Pioglitazone on Renal Hemodynamics (time frame: 2008). The study lists 3 primary outcomes in all. 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 NCT01090752, which also lists 2 linked publications.

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 8 Apr 2010.