NCT00969956

Brief Summary

Diabetes causing serious complications is well known. In this study the aim is to follow 950 patients with diabetes for 15 years to study when, in who and how the diabetes complications occurs.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

5.8 years

First QC Date

September 1, 2009

Last Update Submit

August 17, 2022

Conditions

RetinopathyNephropathyDiabetic NeuropathyVascular DiseaseIschemic Heart Disease

Keywords

Diabetes, Complication, Cardio-vascular disease

Outcome Measures

Primary Outcomes (5)

  • Time to nephropathy

    0, 3-5, 8-10 and 13-15 years

  • Time to autonomous neuropathic ulcers and Amputation

    0, 3-5, 8-10 and 13-15 years

  • Time to peripheral neuropathy

    0, 3-5, 8-10 and 13-15 years

  • Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation

    0, 3-5, 8-10 and 13-15 years

  • Time to retinopathy

    0, 3-5, 8-10 and 13-15 years

Secondary Outcomes (14)

  • DNA

    0, 3-5, 8-10 and 13-15 years

  • Endothelial markers

    0, 3-5, 8-10 and 13-15 years

  • Blood lipids

    0, 3-5, 8-10 and 13-15 years

  • CRP

    0, 3-5, 8-10 and 13-15 years

  • Oxidative stress

    0, 3-5, 8-10 and 13-15 years

  • +9 more secondary outcomes

Study Arms (4)

Group A

150 Type 1 Diabetes, duration of 15 years (+/- 2 years) and 150 Type 2 Diabetes, duration of 2 years (+/- 2 years) (50% women / men)

Group B

150 Type 1 Diabetes, duration of 20 years (+/- 2 years) and 150 Type 2 Diabetes, duration of 7 years (+/- 2 years) (50% women / men)

Group C

150 Type 1 Diabetes, duration of 25 years (+/- 2 years) and 150 Type 2 Diabetes duration of 12 years (+/- 2 years) (50% women / men)

Group D

50 LADA (Late Autoimmune Diabetes in Adults), debut after 35 years of age, duration of 5-10 years (50% women / men)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Typ 1, Typ 2 and LADA Diabetics from the diabetic clinic at Sophiahemmet, Stockholm, Sweden

You may qualify if:

  • Diabetes type 1, 2 or LADA: 18-75 years of age.
  • Group A: 150 Type 1 Diabetes, duration 15 years (+/-2 years) and 150 Type 2
  • Diabetes 2 years (+/-2 years) (50% F/M)
  • Group B: 150 Type 1 Diabetes, duration 20 years (+/-2 years) and 150 Type 2
  • Diabetes 7 years (+/-2 years) (50% F/M)
  • Group C: 150 Type 1 Diabetes, duration 25 years (+/-2 years) and 150 Type 2
  • Diabetes 12 years (+/-2 years) (50% F/M)
  • Group D: 50 LADA, onset after 35 years of age, duration of 5-10 years (50% F/M)
  • Type 1 Diabetes: Positive ICA antibodies and/or GAD-antibodies and/or neg C-peptide. Debut \<30 years of age.
  • Type 2 Diabetes: Negative ICA-antibodies and GAD-antibodies and pos C-peptide (\>0.35 mmol/l).
  • LADA: Positive ICA-antibodies and/or GAD-antibodies. Debut \>35 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Molecular Medicine and Surgery, Rolf Luft Research centre for Diabetes and Endocrinology

Stockholm, 171 76, Sweden

Location

Related Publications (19)

  • Gaede P, Pedersen O. Intensive integrated therapy of type 2 diabetes: implications for long-term prognosis. Diabetes. 2004 Dec;53 Suppl 3:S39-47. doi: 10.2337/diabetes.53.suppl_3.s39.

    PMID: 15561920BACKGROUND

  • Genuth S. Insights from the diabetes control and complications trial/epidemiology of diabetes interventions and complications study on the use of intensive glycemic treatment to reduce the risk of complications of type 1 diabetes. Endocr Pract. 2006 Jan-Feb;12 Suppl 1:34-41. doi: 10.4158/EP.12.S1.34.

    PMID: 16627378BACKGROUND

  • Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.

    PMID: 18200806BACKGROUND

  • Brismar K, Fernqvist-Forbes E, Wahren J, Hall K. Effect of insulin on the hepatic production of insulin-like growth factor-binding protein-1 (IGFBP-1), IGFBP-3, and IGF-I in insulin-dependent diabetes. J Clin Endocrinol Metab. 1994 Sep;79(3):872-8. doi: 10.1210/jcem.79.3.7521354.

    PMID: 7521354BACKGROUND

  • Penckofer S, Kouba J, Wallis DE, Emanuele MA. Vitamin D and diabetes: let the sunshine in. Diabetes Educ. 2008 Nov-Dec;34(6):939-40, 942, 944 passim. doi: 10.1177/0145721708326764.

    PMID: 19075078BACKGROUND

  • Vinik AI, Maser RE, Mitchell BD, Freeman R. Diabetic autonomic neuropathy. Diabetes Care. 2003 May;26(5):1553-79. doi: 10.2337/diacare.26.5.1553.

    PMID: 12716821BACKGROUND

  • Kotronen A, Lewitt M, Hall K, Brismar K, Yki-Jarvinen H. Insulin-like growth factor binding protein 1 as a novel specific marker of hepatic insulin sensitivity. J Clin Endocrinol Metab. 2008 Dec;93(12):4867-72. doi: 10.1210/jc.2008-1245. Epub 2008 Sep 16.

    PMID: 18796514BACKGROUND

  • King GL. The role of inflammatory cytokines in diabetes and its complications. J Periodontol. 2008 Aug;79(8 Suppl):1527-34. doi: 10.1902/jop.2008.080246.

    PMID: 18673007BACKGROUND

  • Pop-Busui R. Cardiac autonomic neuropathy in diabetes: a clinical perspective. Diabetes Care. 2010 Feb;33(2):434-41. doi: 10.2337/dc09-1294. No abstract available.

    PMID: 20103559BACKGROUND

  • Pickup JC. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. Diabetes Care. 2004 Mar;27(3):813-23. doi: 10.2337/diacare.27.3.813.

    PMID: 14988310BACKGROUND

  • Gomes F, Telo DF, Souza HP, Nicolau JC, Halpern A, Serrano CV Jr. Obesity and coronary artery disease: role of vascular inflammation. Arq Bras Cardiol. 2010 Feb;94(2):255-61, 273-9, 260-6. doi: 10.1590/s0066-782x2010000200021. English, Portuguese, Spanish.

    PMID: 20428625BACKGROUND

  • Arai Y, Kojima T, Takayama M, Hirose N. The metabolic syndrome, IGF-1, and insulin action. Mol Cell Endocrinol. 2009 Feb 5;299(1):124-8. doi: 10.1016/j.mce.2008.07.002. Epub 2008 Jul 11.

    PMID: 18672019BACKGROUND

  • Eriksson A, Attvall S, Bonnier M, Eriksson JW, Rosander B, Karlsson FA. Short-term effects of metformin in type 2 diabetes. Diabetes Obes Metab. 2007 Jul;9(4):483-9. doi: 10.1111/j.1463-1326.2006.00624.x.

    PMID: 17587390BACKGROUND

  • Galic S, Oakhill JS, Steinberg GR. Adipose tissue as an endocrine organ. Mol Cell Endocrinol. 2010 Mar 25;316(2):129-39. doi: 10.1016/j.mce.2009.08.018. Epub 2009 Aug 31.

    PMID: 19723556BACKGROUND

  • Salpeter SR, Buckley NS, Kahn JA, Salpeter EE. Meta-analysis: metformin treatment in persons at risk for diabetes mellitus. Am J Med. 2008 Feb;121(2):149-157.e2. doi: 10.1016/j.amjmed.2007.09.016.

    PMID: 18261504BACKGROUND

  • Orchard TJ, Temprosa M, Goldberg R, Haffner S, Ratner R, Marcovina S, Fowler S; Diabetes Prevention Program Research Group. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial. Ann Intern Med. 2005 Apr 19;142(8):611-9. doi: 10.7326/0003-4819-142-8-200504190-00009.

    PMID: 15838067BACKGROUND

  • Alagona P Jr. Beyond LDL cholesterol: the role of elevated triglycerides and low HDL cholesterol in residual CVD risk remaining after statin therapy. Am J Manag Care. 2009 Mar;15(3 Suppl):S65-73.

    PMID: 19355805BACKGROUND

  • Hemmingsen B, Lund SS, Gluud C, Vaag A, Almdal TP, Hemmingsen C, Wetterslev J. Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2013 Nov 11;(11):CD008143. doi: 10.1002/14651858.CD008143.pub3.

    PMID: 24214280BACKGROUND

  • Fullerton B, Jeitler K, Seitz M, Horvath K, Berghold A, Siebenhofer A. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2014 Feb 14;2014(2):CD009122. doi: 10.1002/14651858.CD009122.pub2.

    PMID: 24526393BACKGROUND

MeSH Terms

Conditions

Retinal DiseasesKidney DiseasesDiabetic NeuropathiesVascular DiseasesMyocardial IschemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Eye DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesCardiovascular DiseasesHeart DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kerstin Brismar, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

April 1, 2012

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations

SE(1)