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Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes (SDIS)

Primary Purpose

Coronary Heart Disease, Stroke, Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intensive insulin treatment
Standard insulin treatment
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 52 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Born 1930 or later
  • Type 1 diabetes
  • Nonproliferative retinopathy
  • Normal serum creatinine
  • Unsatisfactory blood glucose control

Exclusion Criteria:

  • Alcohol/drug abuse
  • Proliferative retinopathy

Sites / Locations

  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive insulin treatment

Standard insulin treatment

Arm Description

Intensive insulin treatment

Standard insulin treatment

Outcomes

Primary Outcome Measures

Cardiovascular Mortality
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure

Secondary Outcome Measures

Morbidity of Cardiovascular Complications
Morbidity of: coronary heart disease, stroke and renal failure

Full Information

First Posted
May 9, 2014
Last Updated
August 31, 2016
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02138006
Brief Title
Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes
Acronym
SDIS
Official Title
Stockholm Diabetes Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 1982 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
Detailed Description
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits. In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Stroke, Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive insulin treatment
Arm Type
Experimental
Arm Description
Intensive insulin treatment
Arm Title
Standard insulin treatment
Arm Type
Active Comparator
Arm Description
Standard insulin treatment
Intervention Type
Drug
Intervention Name(s)
Intensive insulin treatment
Other Intervention Name(s)
Basal-bolus insulin treatment
Intervention Description
Mealtime insulin (Actrapid) Basal insulin (Monotard)
Intervention Type
Drug
Intervention Name(s)
Standard insulin treatment
Other Intervention Name(s)
Mixed insulin 2-3 times per day
Intervention Description
Insulin Mixtard
Primary Outcome Measure Information:
Title
Cardiovascular Mortality
Description
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
Time Frame
Up to 28 years
Secondary Outcome Measure Information:
Title
Morbidity of Cardiovascular Complications
Description
Morbidity of: coronary heart disease, stroke and renal failure
Time Frame
Up to 28 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Born 1930 or later Type 1 diabetes Nonproliferative retinopathy Normal serum creatinine Unsatisfactory blood glucose control Exclusion Criteria: Alcohol/drug abuse Proliferative retinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Nyström, Md, PhD
Organizational Affiliation
Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
8147960
Citation
Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med. 1993 Jul 29;329(5):304-9. doi: 10.1056/NEJM199307293290502.
Results Reference
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PubMed Identifier
8772731
Citation
Jensen-Urstad KJ, Reichard PG, Rosfors JS, Lindblad LE, Jensen-Urstad MT. Early atherosclerosis is retarded by improved long-term blood glucose control in patients with IDDM. Diabetes. 1996 Sep;45(9):1253-8. doi: 10.2337/diab.45.9.1253.
Results Reference
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PubMed Identifier
3048052
Citation
Reichard P, Britz A, Cars I, Nilsson BY, Sobocinsky-Olsson B, Rosenqvist U. The Stockholm Diabetes Intervention Study (SDIS): 18 months' results. Acta Med Scand. 1988;224(2):115-22. doi: 10.1111/j.0954-6820.1988.tb16748.x.
Results Reference
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PubMed Identifier
8288056
Citation
Reichard P, Pihl M. Mortality and treatment side-effects during long-term intensified conventional insulin treatment in the Stockholm Diabetes Intervention Study. Diabetes. 1994 Feb;43(2):313-7. doi: 10.2337/diab.43.2.313.
Results Reference
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PubMed Identifier
24802206
Citation
Rathsman B, Jensen-Urstad K, Nystrom T. Intensified insulin treatment is associated with improvement in skin microcirculation and ischaemic foot ulcer in patients with type 1 diabetes mellitus: a long-term follow-up study. Diabetologia. 2014 Aug;57(8):1703-10. doi: 10.1007/s00125-014-3248-2. Epub 2014 May 7.
Results Reference
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Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes

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