RetinopathyNCT00969956
Time To Complications Occurs in Diabetes
An observational study of Retinopathy and Nephropathy, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Retinopathy, Nephropathy, Diabetic Neuropathy
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2012to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Typ 1, Typ 2 and LADA Diabetics from the diabetic clinic at Sophiahemmet, Stockholm, Sweden
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Molecular Medicine and Surgery, Rolf Luft Research centre for Diabetes and Endocrinology
Stockholm, 171 76
About this study
Official title: 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.
Read the detailed description
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).
- Keywords
- Diabetes, Complication, Cardio-vascular disease
- Medical subject headings
- Retinal Diseases, Kidney Diseases, Diabetic Neuropathies, Vascular Diseases, Myocardial Ischemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to nephropathy
Measured: 0, 3-5, 8-10 and 13-15 years
Time to autonomous neuropathic ulcers and Amputation
Measured: 0, 3-5, 8-10 and 13-15 years
Time to peripheral neuropathy
Measured: 0, 3-5, 8-10 and 13-15 years
Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation
Measured: 0, 3-5, 8-10 and 13-15 years
Time to retinopathy
Measured: 0, 3-5, 8-10 and 13-15 years
Secondary outcomes (14)
DNA
Measured: 0, 3-5, 8-10 and 13-15 years
Endothelial markers
Measured: 0, 3-5, 8-10 and 13-15 years
Blood lipids
Measured: 0, 3-5, 8-10 and 13-15 years
CRP
Measured: 0, 3-5, 8-10 and 13-15 years
Oxidative stress
Measured: 0, 3-5, 8-10 and 13-15 years
Q10
Measured: 0, 3-5, 8-10 and 13-15 years
IGFBP-1
Measured: 0, 3-5, 8-10 and 13-15 years
IGF-1
Measured: 0, 3-5, 8-10 and 13-15 years
Inflammatory markers
Measured: 0, 3-5, 8-10 and 13-15 years
Seated blood pressure
Measured: 0, 3-5, 8-10 and 13-15 years
Pulse
Measured: 0, 3-5, 8-10 and 13-15 years
Weight
Measured: 0, 3-5, 8-10 and 13-15 years
BMI
Measured: 0, 3-5, 8-10 and 13-15 years
Waistlines
Measured: 0, 3-5, 8-10 and 13-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startApr 2012
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Local regulations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Bonnier, Karolinska Institutet
- Investigators
- Kerstin Brismar, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969956
- Sponsor's protocol ID
- TTCOD
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2009
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.2337/diabetes.53.suppl_3.s39.
PubMed 15561920Genuth 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.
PubMed 16627378Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
PubMed 18200806Brismar 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.
PubMed 7521354Penckofer 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.
PubMed 19075078Vinik 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.
PubMed 12716821Kotronen 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.
PubMed 18796514King 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.
PubMed 18673007Pop-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.
PubMed 20103559Pickup 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.
PubMed 14988310Gomes 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.
PubMed 20428625Arai 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.
PubMed 18672019Eriksson 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.
PubMed 17587390Galic 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.
PubMed 19723556Salpeter 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.
PubMed 18261504
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Complications Occurs in Diabetes. Risk Factors Determine When Diabetes Complications Occur
- ClinicalTrials.gov ID
- NCT00969956
- Acronym / sponsor ID
- TTCOD
- Keywords
- Diabetes, Complication, Cardio-vascular disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Local regulations
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Typ 1, Typ 2 and LADA Diabetics from the diabetic clinic at Sophiahemmet, Stockholm, Sweden
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to nephropathy
Time frame: 0, 3-5, 8-10 and 13-15 years
Time to autonomous neuropathic ulcers and Amputation
Time frame: 0, 3-5, 8-10 and 13-15 years
Time to peripheral neuropathy
Time frame: 0, 3-5, 8-10 and 13-15 years
Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation
Time frame: 0, 3-5, 8-10 and 13-15 years
Time to retinopathy
Time frame: 0, 3-5, 8-10 and 13-15 years
14 secondary outcomes
DNA
Time frame: 0, 3-5, 8-10 and 13-15 years
Endothelial markers
Time frame: 0, 3-5, 8-10 and 13-15 years
Blood lipids
Time frame: 0, 3-5, 8-10 and 13-15 years
CRP
Time frame: 0, 3-5, 8-10 and 13-15 years
Oxidative stress
Time frame: 0, 3-5, 8-10 and 13-15 years
Q10
Time frame: 0, 3-5, 8-10 and 13-15 years
IGFBP-1
Time frame: 0, 3-5, 8-10 and 13-15 years
IGF-1
Time frame: 0, 3-5, 8-10 and 13-15 years
Inflammatory markers
Time frame: 0, 3-5, 8-10 and 13-15 years
Seated blood pressure
Time frame: 0, 3-5, 8-10 and 13-15 years
Pulse
Time frame: 0, 3-5, 8-10 and 13-15 years
Weight
Time frame: 0, 3-5, 8-10 and 13-15 years
BMI
Time frame: 0, 3-5, 8-10 and 13-15 years
Waistlines
Time frame: 0, 3-5, 8-10 and 13-15 years
Results and safety
The study was stopped early (reason given: Local regulations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Background: PubMed 15561920Gaede 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.
- Background: PubMed 16627378Genuth 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.
- Background: PubMed 18200806Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
- Background: PubMed 7521354Brismar 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.
- Background: PubMed 19075078Penckofer 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.
- Background: PubMed 12716821Vinik 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.
- Background: PubMed 18796514Kotronen 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.
- Background: PubMed 18673007King 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.
- Background: PubMed 20103559Pop-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.
- Background: PubMed 14988310Pickup 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.
- Background: PubMed 20428625Gomes 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.
- Background: PubMed 18672019Arai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Brismar, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy and Nephropathy, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Local regulations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to nephropathy (time frame: 0, 3-5, 8-10 and 13-15 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969956, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.