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

April 2, 2019 updated by: Peter Gæde
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Slagelse, Denmark, 4200
        • Slagelse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Exercise
Behavioral: Diet
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: Exercise
Behavioral: Diet
Behavioral: Stop smoking
Drug: Glucose lowering therapy
Drug: Blood pressure lowering therapy
Drug: Lipid lowering therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diabetic nephropathy
Time Frame: Four years
Four years
Combined cardiovascular endpoint
Time Frame: Eight years
Eight years
Total mortality
Time Frame: 13 years
13 years
Years of life years gained
Time Frame: 21 years
21 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 22 years
22 years
Cardiovascular disease mortality
Time Frame: 22 years
22 years
Stroke
Time Frame: 22 years
22 years
Myocardial infarction
Time Frame: 22 years
22 years
Coronary interventions
Time Frame: 22 years
22 years
Amputations
Time Frame: 22 years
22 years
Vascular surgery
Time Frame: 22 years
22 years
Diabetic retinopathy
Time Frame: 22 years
22 years
Diabetic nephropathy
Time Frame: 22 years
22 years
Diabetic neuropathy
Time Frame: 22 years
22 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Gæde

Investigators

  • Study Director: Peter Gaede, Professor, Slagelse Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1992

Primary Completion (Actual)

December 1, 2001

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 27, 2006

First Submitted That Met QC Criteria

April 27, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA92071gm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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