Clinical Trials Logo
  1. Home
  2. Neuropathy, Diabetic
  3. NCT00422955
  4. Details
NCT00422955 Clinical Trial

Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Neuropathy, Diabetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00422955
Other study ID # 49653/376
Secondary ID
Status Completed
Phase Phase 3
First received January 15, 2007
Last updated September 13, 2016
Start date November 2003
Est. completion date October 2005

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rosiglitazone

Locations
Country Name City State
Netherlands GSK Investigational Site Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
Secondary Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.
See also
  Status Clinical Trial Phase
Completed NCT03195868 - Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy N/A
Completed NCT05703152 - Effect of a Combined Exercise Program on Neuropathic Pain and Perceived Quality of Life in Type 2 Diabetes N/A
Not yet recruiting NCT05783700 - Identification of Biomarkers for the Study of the Diabetic Foot and Evolution.
Not yet recruiting NCT05546138 - Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy
Recruiting NCT03989063 - Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes N/A
Completed NCT03495089 - DECODING Study (Dermal Electrochemical Conductance in Diabetic Neuropathy) N/A
Completed NCT04327622 - Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
Recruiting NCT06376240 - The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes N/A
Completed NCT00643760 - A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN) Phase 2
Completed NCT04287439 - Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life N/A
Terminated NCT03777956 - The Effect of Lacosamide in Peripheral Neuropathic Pain Phase 2
Recruiting NCT05291975 - Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain N/A
Not yet recruiting NCT05843929 - Prevalence of the Appearance of Diabetic Ulcers in Patients With 3D Insole and LSCI. N/A
Completed NCT05127538 - Balance and Gait in Diabetic Neuropathy N/A
Completed NCT03847129 - Assessments and Interventions for Hand Neuropathy in DM N/A
Completed NCT03700580 - Clinical Trial Using the Proteolytic Fraction P1G10 From V. Cundinamarcensis to Heal Diabetic Foot Ulcer Phase 2
Completed NCT04078516 - Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)

External Links