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Time To Complications Occurs in Diabetes

17. august 2022 opdateret af: Mats Bonnier, Karolinska Institutet

Time to Complications Occurs in Diabetes. Risk Factors Determine When Diabetes Complications Occur

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.

Studieoversigt

Detaljeret beskrivelse

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:

  1. Genetic factors determine increased risk of early onset of complications.
  2. Oxidative stress increases the risk of complications.
  3. Inflammation, hyperlipidemia and hypertension leads to hypoxia and oxidative stress.
  4. Combined hypoxia and hyperglycemia leads to complications.

Questionnaires:

  1. Are there measurable risk factors that indicate different sensitivity to develop diabetes complications?
  2. Are there differences between men and women?
  3. 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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

17

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time to nephropathy
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Time to autonomous neuropathic ulcers and Amputation
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Time to peripheral neuropathy
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Time to retinopathy
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years

Sekundære resultatmål

Resultatmål
Tidsramme
DNA
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Endothelial markers
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Blood lipids
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
CRP
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Oxidative stress
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Q10
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
IGFBP-1
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
IGF-1
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Inflammatory markers
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Seated blood pressure
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Pulse
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Weight
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
BMI
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years
Waistlines
Tidsramme: 0, 3-5, 8-10 and 13-15 years
0, 3-5, 8-10 and 13-15 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2012

Primær færdiggørelse (Faktiske)

1. februar 2018

Studieafslutning (Faktiske)

1. februar 2018

Datoer for studieregistrering

Først indsendt

1. september 2009

Først indsendt, der opfyldte QC-kriterier

1. september 2009

Først opslået (Skøn)

2. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2022

Sidst verificeret

1. august 2022

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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