EUCTR2008-001634-28-GB
Active, not recruiting
Not Applicable
Identification of genetic and functional biomarkers that predict PPAR-gamma-associated fluid retention and oedema
niversity of Dundee0 sitesAugust 12, 2008
DrugsActos (Pioglitazone)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Dundee
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Once selected from the DARTS database, patients must fulfill all of the following criteria:
- •1\.Between 30 and 70 inclusive
- •2\.Type 2 diabetes mellitus
- •3\.Non\-insulin dependent
- •4\.BMI 20\-35 kg/m2
- •5\.HbA1c \=15% within last 12 months
- •6\.BP \=160/100 mmHg
- •7\.Ability to understand and willingness to sign the informed consent form
- •8\.Willing to discontinue oral agents for 2 weeks prior to the study
- •9\.Willing to initiate TZD therapy for the duration of the study
Exclusion Criteria
- •Patients in both cohorts are to be excluded from the study if they meet any of the following criteria:
- •1\.Patients with existing peripheral oedema
- •2\.Pregnant or lactating women
- •3\.Known to be HIV\-positive
- •4\.Known active hepatitis B and/or hepatitis C infection
- •5\.Patients currently receiving diuretics and/or calcium channel blockers
- •6\.History of symptomatic heart failure (NYHA Classes II, III, IV) or LV systolic ejection fraction \<40%)
- •7\.Acute cardiovascular event within 6 months before screening including myocardial infarction, cerebrovascular accident, cardiac disturbance, evidence of acute or unstable chronic pulmonary disease or lesions at chest radiograph
- •8\.History of TZD intolerance or currently receiving TZD therapy
- •9\.Significant renal or hepatic dysfunction (\>2\.5 xULN ALT; creatinine \>130 µmol/L)
Outcomes
Primary Outcomes
Not specified
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