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We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).
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 randomiz (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 study, 96 patients from the SDIS study were asked to participate in current study and to investigate their skin microcirculation, in which 72 patients agreed (ICT; n=35 vs. ST; n=37). Also, nineteen healthy subjects participated as controls for the method of iontophoresis, with no intention to be followed-up. Exclusions criteria were; any history or ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. The iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization ceased (7.5 years). All participants (except the control subjects) were then followed-up until first time hospitalization for ischemic foot ulcer or until 31 december 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensified insulin treatment | Experimental | Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day |
|
| Standard treatment | Active Comparator | Mixed Insulin (2-3 times a day) |
|
| Healthy controls | No Intervention | These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up- |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensified insulin treatment | Drug | The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic Foot Ulcer | The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code | Until hospitalization for ischemic foot ulcer or until 31 December 2011 |
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| Measure | Description | Time Frame |
|---|---|---|
| Microvascular Endothelial Function | Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response. | 7 years |
Inclusion Criteria:
Born 1930 or later, Type 1 diabetes appearing at age 30 or earlier and with insulin dependency within 1 year from diagnosis, no known abuse of alcohol or drugs, non-prolipherative retinopathy of any degree present, no previous photocoagulation, normal serum creatinine, unsatsifactory blood glucose control according to the physician in charge of the patients.
Exclusion Criteria:
Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Nyström, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset | Stockholm | 118 83 | Sweden | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensified Insulin Treatment | Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. |
| FG001 | Standard-treatment | Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months |
| FG002 | Healthy Controls | 19 healthy controls were invited to compare microcirculation between healthy and diabetes individuals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensified Insulin Treatment | Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. |
| BG001 | Standard-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 | Ischemic Foot Ulcer | The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code | Data for Healthy Controls was not collected for this Outcome Measure. | Posted | Number | participants | Until hospitalization for ischemic foot ulcer or until 31 December 2011 |
|
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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 | Intensified Insulin Treatment | Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 0 | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Nyström | Karolinska Institutet Södersjukhuset | +46704325214 | thomas.nystrom@sodersjukhuset.se |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Standard treatment | Drug | Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months |
|
|
| Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB |
| Stockholm |
| 118 83 |
| Sweden |
| 24802206 | Derived | 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. |
Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months |
| BG002 | Healthy Control | Solely controls for the iontophoresis method and no intention to be followd-up. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Other Pre-specified | Microvascular Endothelial Function | Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response. | Not Posted | 7 years | Participants |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Standard-treatment | Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months | 0 | 37 | 0 | 37 |
| EG002 | Healthy Controls | These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up. | 0 | 19 | 0 | 19 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |