- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00969956
Time To Complications Occurs in Diabetes
Time to Complications Occurs in Diabetes. Risk Factors Determine When Diabetes Complications Occur
Panoramica dello studio
Stato
Descrizione dettagliata
Background:
That diabetes cause serious diabetic complications from the eyes, kidneys, nerves and large vessels is known. Good metabolic control during the first 8-10 years has been shown to delay and even alleviate diabetes complications, but not entirely prevent them. When complications occur early after diabetes onset there are also likely genetic causes. If the various diabetes complications have different formation mechanisms or different sensitivity of blood sugar impact is not studied previously.
Hypothesis:
- Genetic factors determine increased risk of early onset of complications.
- Oxidative stress increases the risk of complications.
- Inflammation, hyperlipidemia and hypertension leads to hypoxia and oxidative stress.
- Combined hypoxia and hyperglycemia leads to complications.
Questionnaires:
- Are there measurable risk factors that indicate different sensitivity to develop diabetes complications?
- Are there differences between men and women?
- Are there differences between type 1 and type 2 diabetes?
Knowledge achievements:
Being able to anticipate and prevent diabetes complications with specific approaches would mean major benefits for patients and society.
Inclusions 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% K / M) Group B: 150 Type 1 Diabetes, duration 20 years (+/- 2 years) and 150 Type 2 Diabetes 7 years (+/- 2 years) (50% K / M) Group C: 150 Type 1 Diabetes, duration 25 years (+/- 2 years) and 150 Type 2 Diabetes 12 years (+/- 2 years) (50% K / M) Group D: 50 LADA, onset after 35 years of age, duration of 5-10 years (50% K / M)
Follow-up visits:
Group A: After 3, 8 and 13 years Group B: After 5, 10 and 15 years Group C: After 5, 10 and 15 years Group D: After 3, 8 and 13 years
Definitions:
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.
Retinopathy: Level of retinopathy based on fundus photography judged by experienced ophthalmologist and classified according to DRP classification in five steps: 1. No retinopathy, 2. Mild non-proliferative retinopathy, 3. Moderate non-proliferative retinopathy, 4. Severe non-proliferative retinopathy, 5. Proliferative retinopathy
ESRD (end stage renal disease): Dialysis or transplantation demanding, GFR (glomerular filtration rate) <10 ml/min.
Overt nephropathy: Albumin excretion at least two consecutive measurements,≥ 300 mg/L and/or S-Creatinine > 100 women and > 110 mmol/l in men.
Incipient nephropathy: Albuminuria between 30 - 300mg/L or Urine albumin/Creatinine >3.
Hypertension: Measured blood pressure in sitting position after 10 minutes rest, at least two consecutive measurements with at least 4 weeks in between, ≥ 130/80.
Hyperlipidemia: ApoA-1/ApoB: >0.5 and/or Triglycerides >1,7 mmol/L and/or LDL >2.5 mmol/L and/or HDL women <1.3, men <1.1 mmol/L and/or cholesterol >4.5 mmol/L.
Heart disease: History of myocardial infarction, angina pectoris and/or ischemic heart disease (file noted). Pharmacological treatment for ischemic heart disease, heart failure or pathological electrocardiographic changes according to Minnesota code.
Cerebrovascular disease: Deemed to have been: if recorded in the patients file and/or if pathological findings demonstrated on CT/MR.
Peripheral vascular disease: Ankle Index <0.9 (blood pressure arm>ankle) Clinical macroangiopathy, (absence of peripheral pulse) or history typical for claudication intermittens.
Neuropathy: Foot investigation: According to international consensus for the investigation and risk assessment of diabetic feet with a view of peripheral autonomic neuropathy (PAN) and peripheral sensory neuropathy (PSN).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Stockholm, Svezia, 171 76
- Department of Molecular Medicine and Surgery, Rolf Luft Research centre for Diabetes and Endocrinology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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)
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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)
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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)
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Group D
50 LADA (Late Autoimmune Diabetes in Adults), debut after 35 years of age, duration of 5-10 years (50% women / men)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Time to nephropathy
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Time to autonomous neuropathic ulcers and Amputation
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Time to peripheral neuropathy
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
|
Time to retinopathy
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
DNA
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
|
Endothelial markers
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
|
0, 3-5, 8-10 and 13-15 years
|
Blood lipids
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
|
0, 3-5, 8-10 and 13-15 years
|
CRP
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
|
0, 3-5, 8-10 and 13-15 years
|
Oxidative stress
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
|
Q10
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
|
IGFBP-1
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
|
0, 3-5, 8-10 and 13-15 years
|
IGF-1
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
|
0, 3-5, 8-10 and 13-15 years
|
Inflammatory markers
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Seated blood pressure
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Pulse
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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Weight
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
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BMI
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
|
Waistlines
Lasso di tempo: 0, 3-5, 8-10 and 13-15 years
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0, 3-5, 8-10 and 13-15 years
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie del sistema nervoso
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie del sistema endocrino
- Complicanze del diabete
- Diabete mellito
- Malattie neuromuscolari
- Malattie del sistema nervoso periferico
- Malattia coronarica
- Malattie cardiache
- Disfunsione dell'arteria coronaria
- Ischemia miocardica
- Malattie vascolari
- Neuropatie diabetiche
Altri numeri di identificazione dello studio
- TTCOD
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