Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

NCT00422955 | Completed Phase 3

• 1 other identifier: 49653/376
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathy, Diabetic

Keywords

fluid retention; Autonomic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in transcapillary escape rate of L125 albumin following 16 weeks treatment

Secondary Outcomes (1)

• Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: rosiglitazone

Interventions

rosiglitazone DRUG

Arm 1

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Nijmegen, 6525 EZ, Netherlands

Location

Related Publications (1)

• Rennings AJ, Smits P, Stewart MW, Tack CJ. Autonomic neuropathy predisposes to rosiglitazone-induced vascular leakage in insulin-treated patients with type 2 diabetes: a randomised, controlled trial on thiazolidinedione-induced vascular leakage. Diabetologia. 2010 Sep;53(9):1856-66. doi: 10.1007/s00125-010-1787-8. Epub 2010 May 25.

  PMID: 20499046 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: November 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)