Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

A 16-week, Randomised, Double-blind, Placebo-controlled, Single-centre Study to Investigate Fluid Retention in Insulin-treated Subjects With Type 2 Diabetes Mellitus and Varying Degrees of Autonomic Neuropathy When Administered Rosiglitazone 4mg Twice Daily

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422955

Enrollment

Registered

2007-01-17

Start date

2003-11-30

Completion date

2005-10-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy, Diabetic

Keywords

fluid retention, Autonomic Neuropathy

Brief summary

Fluid management study in patients with type 2 diabetes and autonomic neuropathy.

Interventions

DRUGrosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Subjects with Type 2 Diabetes (T2DM) as defined by the 1999 WHO criteria \[World Health Organisation , 1988/NCD/NCS/99.2\] with stable FPG of = 7.0 and = 15.0 mmol/l who have been established on insulin therapy for at least 6 months * BMI = 40 kg.m2 * Subject who is willing and able to provide a signed and dated written informed consent.

Exclusion criteria

* Subjects with an HbA1c level \> 12% * Subjects taking oral hypoglycaemic agents other than metformin * Subjects on insulin dosage \> 200 units/day

Design outcomes

Primary

Measure	Time frame
Change in transcapillary escape rate of L125 albumin following 16 weeks treatment	—

Secondary

Measure	Time frame
Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026