Time To Complications Occurs in Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00969956
First received: September 1, 2009
Last updated: May 15, 2012
Last verified: May 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 July 23, 2014