Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria - Full Text View

Sponsored by:	Steno Diabetes Center
Information provided by:	Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00320008

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

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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

More Information

Publications of Results:

Gaede P, Vedel P, Parving HH, Pedersen O. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet. 1999 Feb 20;353(9153):617-22.

Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93.

Publications indexed to this study:

Gaede P, Valentine WJ, Palmer AJ, Tucker DM, Lammert M, Parving HH, Pedersen O. Cost-effectiveness of intensified versus conventional multifactorial intervention in type 2 diabetes: results and projections from the Steno-2 study. Diabetes Care. 2008 Aug;31(8):1510-5. Epub 2008 Apr 28.

Goede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008 Feb 7;358(6):580-91.

Study ID Numbers:	KA92071gm-KA99035g-KA99035gs
Study First Received:	April 27, 2006
Last Updated:	October 12, 2006
ClinicalTrials.gov Identifier:	NCT00320008
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009