Time To Complications Occurs in Diabetes - Full Text View

Purpose

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.

Condition
Retinopathy Nephropathy Diabetic Neuropathy Vascular Disease Ischemic Heart Disease

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Time to Complications Occurs in Diabetes. Risk Factors Determine When Diabetes Complications Occur

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diabetes Diabetes Complications Diabetic Nerve Problems Heart Diseases Retinal Disorders Vascular Diseases

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

Time to nephropathy [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Time to autonomous neuropathic ulcers and Amputation [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Time to peripheral neuropathy [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Time to retinopathy [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DNA [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Endothelial markers [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Blood lipids [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
CRP [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Oxidative stress [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Q10 [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
IGFBP-1 [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
IGF-1 [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Inflammatory markers [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Seated blood pressure [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Pulse [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Weight [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
BMI [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]
Waistlines [ Time Frame: 0, 3-5, 8-10 and 13-15 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	950
Study Start Date:	April 2012
Estimated Study Completion Date:	May 2027
Estimated Primary Completion Date:	May 2027 (Final data collection date for primary outcome measure)

Groups/Cohorts
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)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969956

Locations

Sweden
Department of Molecular Medicine and Surgery, Rolf Luft Research centre for Diabetes and Endocrinology
Stockholm, Sweden, 171 76

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator:

Kerstin Brismar, Professor

Karolinska Institutet

More Information

Publications:

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

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. Review.

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

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.

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. Review.

Vinik AI, Maser RE, Mitchell BD, Freeman R. Diabetic autonomic neuropathy. Diabetes Care. 2003 May;26(5):1553-79. Review.

Kotronen A, Lewitt M, Hall K, Brismar K, Yki-Järvinen 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. Epub 2008 Sep 16.

King GL. The role of inflammatory cytokines in diabetes and its complications. J Periodontol. 2008 Aug;79(8 Suppl):1527-34. Review.

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

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

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. Review. English, Portuguese, Spanish.

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. Epub 2008 Jul 11. Review.

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.

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

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. Review.

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. Summary for patients in: Ann Intern Med. 2005 Apr 19;142(8):I46.

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. Review.

Responsible Party:	Mats Bonnier, MD, Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00969956 History of Changes
Other Study ID Numbers:	TTCOD
Study First Received:	September 1, 2009
Last Updated:	May 15, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:

Diabetes, Complication, Cardio-vascular disease

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
Diabetic Neuropathies
Heart Diseases
Kidney Diseases
Retinal Diseases
Vascular Diseases
Diabetes Complications
Coronary Disease
Cardiovascular Diseases

Arteriosclerosis
Arterial Occlusive Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Urologic Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013