Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Steno Diabetes Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00320008
First received: April 27, 2006
Last updated: October 12, 2006
Last verified: April 2006
  Purpose

The purpose of this study is to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria


Condition Intervention
Type 2 Diabetes
Behavioral: Diet
Behavioral: Exercise
Behavioral: Stop smoking
Drug: Glucose lowering therapy
Drug: Blood pressure lowering therapy
Drug: Lipid lowering therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Combined cardiovascular endpoint

Secondary Outcome Measures:
  • All cause mortality
  • Cardiovascular disease mortality
  • Stroke
  • Myocardial infarction
  • Coronary interventions
  • Amputations
  • Vascular surgery
  • Diabetic retinopathy
  • Diabetic nephropathy
  • Diabetic neuropathy

Estimated Enrollment: 160
Study Start Date: January 1992
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Microalbuminuria

Exclusion Criteria:

  • Stimulated serum C-peptide concentration less than 600 pmol/L
  • Pancreatic insufficiency or diabetes secondary to pancreatitis
  • Alcohol abuse
  • Non-diabetic kidney disease
  • Life-threatening disease with death probable within 4 years of study start
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320008

Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2620
Sponsors and Collaborators
Steno Diabetes Center
Investigators
Study Director: Peter Gaede, MD Steno Diabetes Center