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Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria (Steno-2)

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ClinicalTrials.gov Identifier: NCT00320008
Recruitment Status : Active, not recruiting
First Posted : April 27, 2006
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Gæde, Steno Diabetes Center Copenhagen

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Diet Behavioral: Exercise Behavioral: Stop smoking Drug: Glucose lowering therapy Drug: Blood pressure lowering therapy Drug: Lipid lowering therapy Not Applicable

Detailed Description:

The overall description of the Steno-2 Study is stated in four protocols approved by the regulatory authorities in Denmark. The protocol identification numbers are KA 92071gm (4 years intervention ), KA-99035g (8 years intervention ), KA-99035-GS (13 years follow-up since intervention start) and H-KA-99035-GS (21 year follow-up since intervention start).

The aim of the study was 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. The primary end point after four years of intervention was to progression to diabetic nephropathy with other microvascular complications as secondary end points. The primary end point after eight years of intervention was a composite CVD endpoint with microvascular complications as secondary end points.

The interventional part of the study was ended in December 2001 after a total of eight years of intervention. From that time on, all patients were followed in a post-trial study. Also, during post-trial period all patients in both original treatment arms received similar treatment resembling the treatment given in the original intensive arm of the study. The aim of the post-trial follow-up was to investigate the effect of intensified multifactorial intervention on i) mortality and ii) years of life gained, respectively, with such an interventional approach.

Endpoints in the two parts of the post-trial follow-up:

Part one at 13 years since start of intervention:

Primary endpoint: Total mortality. Secondary endpoints: Cardiovascular endpoints as defined previously; Microvascular disease.

Part two at 21 years since start of intervention:

Primary endpoint: Difference in median time to 50% mortality in each of the two original treatment groups Secondary endpoints: Cardiovascular endpoints as defined previously; Recurrent cardiovascular events; Microvascular disease.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria
Study Start Date : January 1992
Actual Primary Completion Date : December 2001
Estimated Study Completion Date : December 2025

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
 Behavioral: Diet
Behavioral: Exercise
Behavioral: Stop smoking
Drug: Glucose lowering therapy
Drug: Blood pressure lowering therapy
Drug: Lipid lowering therapy
Experimental: Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
 Behavioral: Diet
Behavioral: Exercise
Behavioral: Stop smoking
Drug: Glucose lowering therapy
Drug: Blood pressure lowering therapy
Drug: Lipid lowering therapy


Outcome Measures
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Primary Outcome Measures :
  1. Diabetic nephropathy [ Time Frame: Four years ]
  2. Combined cardiovascular endpoint [ Time Frame: Eight years ]
  3. Total mortality [ Time Frame: 13 years ]
  4. Years of life years gained [ Time Frame: 21 years ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 22 years ]
  2. Cardiovascular disease mortality [ Time Frame: 22 years ]
  3. Stroke [ Time Frame: 22 years ]
  4. Myocardial infarction [ Time Frame: 22 years ]
  5. Coronary interventions [ Time Frame: 22 years ]
  6. Amputations [ Time Frame: 22 years ]
  7. Vascular surgery [ Time Frame: 22 years ]
  8. Diabetic retinopathy [ Time Frame: 22 years ]
  9. Diabetic nephropathy [ Time Frame: 22 years ]
  10. Diabetic neuropathy [ Time Frame: 22 years ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00320008


Locations
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Denmark
Slagelse Hospital
Slagelse, Denmark, 4200
Sponsors and Collaborators
Peter Gæde
Investigators
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Study Director: Peter Gaede, Professor Slagelse Hospital
More Information
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Publications of Results:

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

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Responsible Party: Peter Gæde, Associate Professor, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT00320008     History of Changes
Other Study ID Numbers: KA92071gm
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases