Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.
- Registration Number
- NCT00422955
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
- Subjects with an HbA1c level > 12%
- Subjects taking oral hypoglycaemic agents other than metformin
- Subjects on insulin dosage > 200 units/day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 rosiglitazone -
- Primary Outcome Measures
Name Time Method Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
- Secondary Outcome Measures
Name Time Method Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link PPAR-γ activation to fluid retention in type 2 diabetes with autonomic neuropathy?
How does rosiglitazone's efficacy in managing fluid retention compare to SGLT2 inhibitors in diabetic autonomic neuropathy?
Which biomarkers correlate with rosiglitazone-induced fluid retention in patients with varying autonomic neuropathy severity?
What adverse event management strategies were implemented for edema in GlaxoSmithKline's NCT00422955 trial?
Are there synergistic effects of combining thiazolidinediones with diuretics for autonomic neuropathy-related fluid retention?
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇱Nijmegen, Netherlands