Renal and Hormonal Effects of Pioglitazone

University Hospitals (UH)

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes

Treatments: Drug: Metformin; Drug: Pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT01090752

FDAAA

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Pioglitazone

Placebo Comparator group

Description:

placebo-controlled, randomized, cross-over study

Treatment:

Drug: Pioglitazone

Drug: Metformin

Metformine

Placebo Comparator group

Description:

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

Treatment:

Drug: Metformin