Identification of genetic and functional biomarkers that predict PPAR-gamma-associated fluid retention and oedema

• Conditions: Patients with Type 2 diabetes mellitus (T2DM) whoa re not receiving insulin treatment; MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent

• Registration Number: EUCTR2008-001634-28-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
Patients in cohort 1 must fulfill the following criterion:
1.Genotype Pro12Ala variant of the PPAR-gamma gene
Patients in cohort 2 must fulfill the following criterion:
1.Genotype Pro12Pro of the PPAR-gamma gene

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)
10.Known drug/alcohol abuse
11.Known psychiatric condition
12.Patients requiring insulin therapy or more than 2 oral anti-diabetic drugs
13.Microalbuminuria (as detected by standard clinical screening methods)
14.Patients with severe varicose veins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified