Trial Outcomes & Findings for Renal and Hormonal Effects of Pioglitazone (NCT NCT01090752)

Results Overview

At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

2008

Results posted on

2010-04-08

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal and Hormonal Effects of Pioglitazone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone Low Salt/High Salt n=8 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase	Placebo Low Salt/High Salt n=8 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	52.5 years STANDARD_DEVIATION 2.8 • n=5 Participants	52.5 years STANDARD_DEVIATION 2.8 • n=7 Participants	52.5 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Switzerland	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 2008

At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF

Outcome measures

Outcome measures
Measure	Pioglitazone Low Salt/High Salt n=16 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase	Placebo Low Salt/High Salt n=16 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
Effects of Pioglitazone on Renal Hemodynamics	68.0 ml/min/1.73m2 Standard Error 4.4	62.4 ml/min/1.73m2 Standard Error 5.0

PRIMARY outcome

Timeframe: 2007

At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances

Outcome measures

Outcome measures
Measure	Pioglitazone Low Salt/High Salt n=16 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase	Placebo Low Salt/High Salt n=16 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
Effects of Pioglitazone on Sodium and Lithium Clearances	1.05 ml/min Standard Error 0.10	1.18 ml/min Standard Error 0.13

PRIMARY outcome

Timeframe: march 2009

24 hour blood pressure measurements were performed after each treatment/diet phase

Outcome measures

Outcome measures
Measure	Pioglitazone Low Salt/High Salt n=16 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase	Placebo Low Salt/High Salt n=16 Participants a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
Effects of Pioglitazone on 24h Blood Pressure Control	128 mmHg Standard Error 5	129 mmHg Standard Error 5

SECONDARY outcome

Timeframe: 2009

Outcome measures

Outcome data not reported

Adverse Events

Pioglitazone Low Salt/High Salt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Low Salt/High Salt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zanchi Anne, MD

University Hospital Geneva and Lausanne, Switzerland

Phone: 0041213140775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place