Stockholm Diabetes Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Intensive insulin treatment
- Conditions
- Coronary Heart Disease
- Sponsor
- Karolinska Institutet
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Cardiovascular Mortality
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Thomas Nystrom
dr
Karolinska Institutet
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
Arms & Interventions
Intensive insulin treatment
Intensive insulin treatment
Intervention: Intensive insulin treatment
Standard insulin treatment
Standard insulin treatment
Intervention: Standard insulin treatment
Outcomes
Primary Outcomes
Cardiovascular Mortality
Time Frame: Up to 28 years
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
Secondary Outcomes
- Morbidity of Cardiovascular Complications(Up to 28 years)