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

Stroke Clinical Trial

— SDIS  

Official title:

Stockholm Diabetes Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138006
• Other study ID #: EPN-2012
• Status: Completed
• Phase: N/A
• First received: May 9, 2014
• Last updated: November 16, 2015
• Start date: September 1982
• Est. completion date: December 2011

Study information

• Verified date: November 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

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 observational 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 52 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Renal Failure
• Stroke

Intervention

Drug:
• Intensive insulin treatment

• Standard insulin treatment

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

Rathsman B, Jensen-Urstad K, Nyström 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Mortality	All cause mortality and composite mortality from myocardial infarction, stroke and renal failure	Up to 28 years	No
Secondary	Morbidity of Cardiovascular Complications (i.e. Coronary Heart Disease and Stroke) and Renal Failure	Morbidity of cardiovascular complications (i.e. coronary heart disease and stroke) and renal failure	Up to 28 years	No