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Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00373178
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : November 2, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: rosiglitazone Drug: metformin Drug: Anti-diabetic medications Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
Study Start Date : January 2005
Primary Completion Date : January 2007
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Metformin,lifestyle counselling Drug: rosiglitazone Drug: metformin Drug: Anti-diabetic medications


Outcome Measures

Primary Outcome Measures :
  1. Novel cardiovascular risk factors modification [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Lipid and glucose regulation [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recently diagnosed type 2 diabetes
  • No previous anti-diabetic medications

Exclusion Criteria:

  • Heart failure
  • Renal disease
  • Liver disease
  • Life-threatening diseases
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373178


Locations
Greece
AHEPA University Hospital of Thessaloniki
Thessaloniki, Greece
Aristotle University of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
University of Athens
Investigators
Study Chair: Miltiadis Alevizos, PhD University Hospital AHEPA,Thessaloniki,Greece
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nikolaos Kadoglou, MD,PhD, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00373178     History of Changes
Other Study ID Numbers: 020401975
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Nikolaos Kadoglou, Aristotle University Of Thessaloniki:
rosiglitazone
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs