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

History of Changes

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:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

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

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.2337/dc07-2452. Epub 2008 Apr 28.

Gaede 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. doi: 10.1056/NEJMoa0706245.


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

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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