Diabetes Mellitus Type 2, Hypertension
Conditions
Keywords
Hypertension
Brief summary
The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.
Interventions
DRUGPioglitazone
45 mg 8 weeks
DRUGPlacebo
Placebo
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 45-75 years * Diabetes mellitus Type 2 (HbA1c 7 - 8.5%) * Casual blood pressure \> = 130/80 mmHg, \< 160/100 mmHg
Exclusion criteria
* Therapy with insulin * Combination therapy of sulfonyl-urea und metformin * Therapy with nateglinid, repaglinid or an other substance of this drug family * Allergy against pioglitazone or other composites of the tablet * History of heart failure (NYHA I bis IV) * Hepatic insufficiency * Transaminases \> 2.5-fold of the upper normal limit * End-stage renal failure * Syndrome of polycystic ovaries * Absence of effective contraception in women of childbearing potential * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median of systolic 24-hour ambulatory blood pressure | 8 weeks | Change of 24-hour blood pressure after 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median of 24-hour diastolic ambulatory blood pressure | 8 weeks | Change of 24-hour diastolic blood pressure after 8 weeks of treatment |
Countries
Germany
Outcome results
None listed