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To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive insulin treatment | Experimental | Intensive insulin treatment |
|
| Standard insulin treatment | Active Comparator | Standard insulin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive insulin treatment | Drug | Mealtime insulin (Actrapid) Basal insulin (Monotard) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Mortality | All cause mortality and composite mortality from myocardial infarction, stroke and renal failure | Up to 28 years |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity of Cardiovascular Complications | Morbidity of: coronary heart disease, stroke and renal failure | Up to 28 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Nyström, Md, PhD | Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 11883 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8147960 | Background | 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. | |
| 8772731 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Insulin Treatment | Intensive insulin treatment Intensive insulin treatment |
| FG001 | Standard Insulin Treatment | Standard insulin treatment Standard insulin treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Insulin Treatment | Intensive insulin treatment Intensive insulin treatment |
| BG001 | Standard Insulin Treatment | Standard insulin treatment Standard insulin treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiovascular Mortality | All cause mortality and composite mortality from myocardial infarction, stroke and renal failure | Posted | Number | participants | Up to 28 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Insulin Treatment | Intensive insulin treatment Intensive insulin treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Nyström | Karolinska Institutet Södersjukhuset | +46704325214 | thomas.nystrom@sodersjukhuset.se |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D020521 | Stroke |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Standard insulin treatment | Drug | Insulin Mixtard |
|
|
| 3048052 | Background | 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. |
| 8288056 | Background | 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. |
| 24802206 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Morbidity of Cardiovascular Complications | Morbidity of: coronary heart disease, stroke and renal failure | Posted | Number | participants | Up to 28 years |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Standard Insulin Treatment | Standard insulin treatment Standard insulin treatment | 0 | 54 | 0 | 54 |
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| D002561 |
| Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |