Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neuropathy, Diabetic	Drug: rosiglitazone	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	November 2003
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1	Drug: rosiglitazone

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
GSK Investigational Site
Nijmegen, Netherlands, 6525 EZ

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Study Data/Documents: Annotated Case Report Form 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 49653/376
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00422955 History of Changes
Other Study ID Numbers:	49653/376
First Posted:	January 17, 2007
Last Update Posted:	September 15, 2016
Last Verified:	September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

fluid retention; Autonomic Neuropathy

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Nervous System Diseases; Edema; Diabetic Neuropathies; Neuromuscular Diseases; Signs and Symptoms	Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Rosiglitazone; Hypoglycemic Agents; Physiological Effects of Drugs