Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Diet; Behavioral: Exercise; Behavioral: Stop smoking; Drug: Glucose lowering therapy; Drug: Blood pressure lowering therapy; Drug: Lipid lowering therapy

• Registration Number: NCT00320008
• Lead Sponsor: Peter Gæde

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.

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 Timeline

• Study Start: 1992-01
• Primary Completion: 2001-12
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment Arm	Glucose lowering therapy	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.
Standard Treatment Arm	Blood pressure lowering therapy	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.
Standard Treatment Arm	Diet	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.
Standard Treatment Arm	Exercise	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.
Standard Treatment Arm	Stop smoking	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.
Intensive Treatment Arm	Stop smoking	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.
Intensive Treatment Arm	Glucose lowering therapy	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.
Intensive Treatment Arm	Diet	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.
Intensive Treatment Arm	Exercise	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.
Standard Treatment Arm	Lipid lowering therapy	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.
Intensive Treatment Arm	Blood pressure lowering therapy	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.
Intensive Treatment Arm	Lipid lowering therapy	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.

Primary Outcome Measures

Name	Time	Method
Diabetic nephropathy	Four years
Combined cardiovascular endpoint	Eight years
Total mortality	13 years
Years of life years gained	21 years

Secondary Outcome Measures

Name	Time	Method
All cause mortality	22 years
Cardiovascular disease mortality	22 years
Stroke	22 years
Myocardial infarction	22 years
Coronary interventions	22 years
Amputations	22 years
Vascular surgery	22 years
Diabetic retinopathy	22 years
Diabetic nephropathy	22 years
Diabetic neuropathy	22 years

Trial Locations

Locations (1)

Slagelse Hospital; 🇩🇰 Slagelse, Denmark