Coronary Heart Disease, Renal Failure, Stroke
Conditions
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.
Interventions
Mealtime insulin (Actrapid) Basal insulin (Monotard)
DRUGStandard insulin treatment
Insulin Mixtard
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 52 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Mortality | Up to 28 years | All cause mortality and composite mortality from myocardial infarction, stroke and renal failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity of Cardiovascular Complications | Up to 28 years | Morbidity of: coronary heart disease, stroke and renal failure |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intensive Insulin Treatment Intensive insulin treatment
Intensive insulin treatment | 48 |
| Standard Insulin Treatment Standard insulin treatment
Standard insulin treatment | 54 |
| Total | 102 |
Baseline characteristics
| Characteristic | Standard Insulin Treatment | Intensive Insulin Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 48 Participants | 102 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 7 | 30 years STANDARD_DEVIATION 8 | 31 years STANDARD_DEVIATION 7 |
| Region of Enrollment Sweden | 54 participants | 48 participants | 102 participants |
| Sex: Female, Male Female | 28 Participants | 26 Participants | 54 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 54 |
| serious Total, serious adverse events | 0 / 48 | 0 / 54 |
Outcome results
Primary
Cardiovascular Mortality
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
Time frame: Up to 28 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Insulin Treatment | Cardiovascular Mortality | 7 participants |
| Standard Insulin Treatment | Cardiovascular Mortality | 11 participants |
p-value: 0.3Log Rank
Secondary
Morbidity of Cardiovascular Complications
Morbidity of: coronary heart disease, stroke and renal failure
Time frame: Up to 28 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Insulin Treatment | Morbidity of Cardiovascular Complications | 6 participants |
| Standard Insulin Treatment | Morbidity of Cardiovascular Complications | 11 participants |