NCT00320008

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 1992

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1992

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
19.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

9.9 years

First QC Date

April 27, 2006

Last Update Submit

April 2, 2019

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

  • Diabetic nephropathy

    Four years

  • Combined cardiovascular endpoint

    Eight years

  • Total mortality

    13 years

  • Years of life years gained

    21 years

Secondary Outcomes (10)

  • All cause mortality

    22 years

  • Cardiovascular disease mortality

    22 years

  • Stroke

    22 years

  • Myocardial infarction

    22 years

  • Coronary interventions

    22 years

  • +5 more secondary outcomes

Study Arms (2)

Standard Treatment Arm

ACTIVE COMPARATOR

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: DietBehavioral: ExerciseBehavioral: Stop smokingDrug: Glucose lowering therapyDrug: Blood pressure lowering therapyDrug: Lipid lowering therapy

Intensive Treatment Arm

EXPERIMENTAL

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: DietBehavioral: ExerciseBehavioral: Stop smokingDrug: Glucose lowering therapyDrug: Blood pressure lowering therapyDrug: Lipid lowering therapy

Interventions

DietBEHAVIORAL
Intensive Treatment ArmStandard Treatment Arm
ExerciseBEHAVIORAL
Intensive Treatment ArmStandard Treatment Arm
Stop smokingBEHAVIORAL
Intensive Treatment ArmStandard Treatment Arm
Glucose lowering therapyDRUG
Intensive Treatment ArmStandard Treatment Arm
Blood pressure lowering therapyDRUG
Intensive Treatment ArmStandard Treatment Arm
Lipid lowering therapyDRUG
Intensive Treatment ArmStandard Treatment Arm

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Microalbuminuria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slagelse Hospital

Slagelse, 4200, Denmark

Location

Related Publications (14)

  • 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. doi: 10.1016/S0140-6736(98)07368-1.

    PMID: 10030326RESULT

  • 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. doi: 10.1056/NEJMoa021778.

    PMID: 12556541RESULT

  • 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.

    PMID: 18256393RESULT

  • Gaede J, Oellgaard J, Ibsen R, Gaede P, Nortoft E, Parving HH, Kjellberg J, Pedersen O. A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study. Diabetologia. 2019 Jan;62(1):147-155. doi: 10.1007/s00125-018-4739-3. Epub 2018 Oct 6.

    PMID: 30293113RESULT

  • Oellgaard J, Gaede P, Persson F, Rossing P, Parving HH, Pedersen O. Application of urinary proteomics as possible risk predictor of renal and cardiovascular complications in patients with type 2-diabetes and microalbuminuria. J Diabetes Complications. 2018 Dec;32(12):1133-1140. doi: 10.1016/j.jdiacomp.2018.09.012. Epub 2018 Sep 24.

    PMID: 30282584RESULT

  • Kjaer LK, Oellgaard J, Henriksen T, Gaede P, Pedersen O, Poulsen HE. Indicator of RNA oxidation in urine for the prediction of mortality in patients with type 2 diabetes and microalbuminuria: A post-hoc analysis of the Steno-2 trial. Free Radic Biol Med. 2018 Dec;129:247-255. doi: 10.1016/j.freeradbiomed.2018.09.030. Epub 2018 Sep 21.

    PMID: 30244028RESULT

  • Oellgaard J, Gaede P, Rossing P, Persson F, Parving HH, Pedersen O. Intensified multifactorial intervention in type 2 diabetics with microalbuminuria leads to long-term renal benefits. Kidney Int. 2017 Apr;91(4):982-988. doi: 10.1016/j.kint.2016.11.023. Epub 2017 Feb 7.

    PMID: 28187983RESULT

  • Oellgaard J, Gaede P, Rossing P, Rorth R, Kober L, Parving HH, Pedersen O. Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 study. Diabetologia. 2018 Aug;61(8):1724-1733. doi: 10.1007/s00125-018-4642-y. Epub 2018 May 30.

    PMID: 29850922RESULT

  • Gaede P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.

    PMID: 27531506RESULT

  • Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.

    PMID: 39171639DERIVED

  • Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.

    PMID: 36975019DERIVED

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PMID: 35224730DERIVED

  • Gaede P, Oellgaard J, Kruuse C, Rossing P, Parving HH, Pedersen O. Beneficial impact of intensified multifactorial intervention on risk of stroke: outcome of 21 years of follow-up in the randomised Steno-2 Study. Diabetologia. 2019 Sep;62(9):1575-1580. doi: 10.1007/s00125-019-4920-3. Epub 2019 Jun 1.

    PMID: 31154479DERIVED

  • 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.

    PMID: 18443195DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter Gaede, Professor

    Slagelse Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

January 1, 1992

Primary Completion

December 1, 2001

Study Completion

December 1, 2025

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)