Type 2 DiabetesNCT04453605
Phenotyping Individuals With Neo-diagnosed Type 2 Diabetes at Risk for All-cause Mortality
An observational study of Type 2 Diabetes and Vascular Diseases, run by University of Pisa at 1 site in Italy.
Trial summary
Prevalence of type 2 diabetes (T2D) is increasing worldwide over the last two decades; in these patients the rate of all-cause and cardiovascular (CV) mortality is several folds higher than in the general population, configuring a major public health problem. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Type 2 Diabetes, Vascular Diseases, Cardiac Disease
- What is being tested?
- standard treatments
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2008to 31 Dec 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria.
Who may be able to join
- age ≥30 years
- personal history of known T2D lasting not more than six months
- diagnosis confirmed on the basis of the OGTT or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl
Who cannot join
- longstanding disease duration
- type 1 diabetes
- diabetes secondary to steroid therapy
- active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining All Cause Morality and Cardiovascular Mortality Risk in Individuals With Neo-diagnosed Type 2 Diabetes
Prevalence of type 2 diabetes (T2D) is increasing worldwide over the last two decades; in these patients the rate of all-cause and cardiovascular (CV) mortality is several folds higher than in the general population, configuring a major public health problem. The clinical phenotype is the main determinant of such high mortality risk; however, a relevant role is played by the disease duration, with a significant interaction with metabolic control. However, for T2D the diagnosis does not correspond to the true onset of the disease, and a high lethality rate also in patients with recent onset of the disease cannot be excluded. Robust evidence supports this hypothesis, showing as in subjects with new-onset T2D, the mortality risk is superimposable, and even higher, than that observed in people with overt and long-term T2D. In this complex scenario, it would be desirable an early identification of high-risk patients, in which an accurate estimation of risk of complications, coupled with appropriate and timely interventions, might help in reducing the risk of encountering premature mortality. The present study was design to address this specific issue.
Read the detailed description
Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria were recruited.
Diagnosis was confirmed on the basis of the Oral Glucose Tolerance Test (OGTT) or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl.
Anthropometric measurements were recorded, arterial pressure and vital parameters were registered, and blood samples were collected for routine analyses. Complete blood count, glucose, HbA1c, Serum Glutamic Oxaloacetic Transaminase (sGOT), Serum Glutamic Pyruvic Transaminase (sGPT), uric acid, were determined by standard techniques. Total and HDL cholesterol and triglycerides were assayed through the automated spectrophotometer, enzymatic colorimetric method, COBAS INTEGRA using commercial kits (Roche Diagnostics). Serum creatinine was measured by Jaffe' method, and estimated glomerular filtration rate (eGFR) was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Previous major acute CV events, including myocardial infarction, stroke, foot ulcer/gangrene/amputation and coronary, carotid and lower limb revascularisation, were adjudicated based on hospital discharge records.
At the end of the baseline visit, patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits, until death or until 31 December 2018. All-cause mortality was assessed by checking the vital status of study participants on 31 December 2018; to this aim, investigators interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
Incident major acute cardiovascular events were registered on the basis of clinical records every year; retinopathy onset was assessed by fundoscopy on a yearly basis.
- Conditions
- Type 2 Diabetes, Vascular Diseases, Cardiac Disease
- Being tested
- standard treatments
- Keywords
- neo-diagnosed type 2 diabetes, all-cause mortality, cardiovascular mortality
- Medical subject headings
- Diabetes Mellitus, Type 2, Vascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentsOther
patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits
| Study group | Role | What they receive |
|---|---|---|
| Patients with neo-diagnosed type 2 diabetes | Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria. Receives: Other: standard treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who died during the study
The number of participants who died during the study was assessed by checking the vital status of study participants on 31 December 2018; to this aim, we interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
Measured: At 31 December 2018
Incidence of cardiovascular disease
Incident major acute cardiovascular events were registered on the basis of clinical records every year
Measured: At 31 December 2018
Incidence of microvascular complication
Retinopathy onset was assessed by fundoscopy on a yearly basis.
Measured: At 31 December 2018
Secondary outcomes (3)
Change of renal function through study completion (an average of 5 year)
Serum creatinine was measured by Jaffe' method and expressed by mg/dl. It was used to calculate eGFR according to the CKD-EPI formula.
Measured: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Change of blood glucose through study completion (an average of 5 year)
Blood glucose was expressed in mg/dl and was determined by standard techniques.
Measured: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Change of HbA1c through study completion (an average of 5 year)
HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.
Measured: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jan 2008
- Primary completion31 Dec 2015
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Solini, University of Pisa
- Investigators
- Anna Solini, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453605
- Sponsor's protocol ID
- AS0006
- Status last verified
- Jun 2020
- First submitted
- 7 May 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.
PubMed 22079683Tancredi M, Rosengren A, Svensson AM, Kosiborod M, Pivodic A, Gudbjornsdottir S, Wedel H, Clements M, Dahlqvist S, Lind M. Excess Mortality among Persons with Type 2 Diabetes. N Engl J Med. 2015 Oct 29;373(18):1720-32. doi: 10.1056/NEJMoa1504347.
PubMed 26510021Gregg EW, Zhuo X, Cheng YJ, Albright AL, Narayan KM, Thompson TJ. Trends in lifetime risk and years of life lost due to diabetes in the USA, 1985-2011: a modelling study. Lancet Diabetes Endocrinol. 2014 Nov;2(11):867-74. doi: 10.1016/S2213-8587(14)70161-5. Epub 2014 Aug 12.
PubMed 25128274Ghouse J, Isaksen JL, Skov MW, Lind B, Svendsen JH, Kanters JK, Olesen MS, Holst AG, Nielsen JB. Effect of diabetes duration on the relationship between glycaemic control and risk of death in older adults with type 2 diabetes. Diabetes Obes Metab. 2020 Feb;22(2):231-242. doi: 10.1111/dom.13891. Epub 2019 Nov 18.
PubMed 31596048Gimeno Orna JA, Blasco Lamarca Y, Campos Gutierrez B, Molinero Herguedas E, Lou Arnal LM. [Morbidity and mortality cardiovascular risk in dependence of type 2 diabetes duration]. Clin Investig Arterioscler. 2014 May-Jun;26(3):122-30. doi: 10.1016/j.arteri.2013.11.010. Epub 2014 Jan 23. Spanish.
PubMed 24461345Herrington WG, Alegre-Diaz J, Wade R, Gnatiuc L, Ramirez-Reyes R, Hill M, Solano-Sanchez M, Baigent C, Lewington S, Collins R, Tapia-Conyer R, Peto R, Kuri-Morales P, Emberson JR. Effect of diabetes duration and glycaemic control on 14-year cause-specific mortality in Mexican adults: a blood-based prospective cohort study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):455-463. doi: 10.1016/S2213-8587(18)30050-0. Epub 2018 Mar 19.
PubMed 29567074Huo L, Magliano DJ, Ranciere F, Harding JL, Nanayakkara N, Shaw JE, Carstensen B. Impact of age at diagnosis and duration of type 2 diabetes on mortality in Australia 1997-2011. Diabetologia. 2018 May;61(5):1055-1063. doi: 10.1007/s00125-018-4544-z. Epub 2018 Feb 22.
PubMed 29473119Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.
PubMed 27881363Smith NL, Barzilay JI, Kronmal R, Lumley T, Enquobahrie D, Psaty BM. New-onset diabetes and risk of all-cause and cardiovascular mortality: the Cardiovascular Health Study. Diabetes Care. 2006 Sep;29(9):2012-7. doi: 10.2337/dc06-0574.
PubMed 16936145
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining All Cause Morality and Cardiovascular Mortality Risk in Individuals With Neo-diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04453605
- Acronym / sponsor ID
- AS0006
- Conditions
- Type 2 Diabetes, Vascular Diseases, Cardiac Disease
- Keywords
- neo-diagnosed type 2 diabetes, all-cause mortality, cardiovascular mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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.
Prevalence of type 2 diabetes (T2D) is increasing worldwide over the last two decades; in these patients the rate of all-cause and cardiovascular (CV) mortality is several folds higher than in the general population, configuring a major public health problem. The clinical phenotype is the main determinant of such high mortality risk; however, a relevant role is played by the disease duration, with a significant interaction with metabolic control. However, for T2D the diagnosis does not correspond to the true onset of the disease, and a high lethality rate also in patients with recent onset of the disease cannot be excluded. Robust evidence supports this hypothesis, showing as in subjects with new-onset T2D, the mortality risk is superimposable, and even higher, than that observed in people with overt and long-term T2D. In this complex scenario, it would be desirable an early identification of high-risk patients, in which an accurate estimation of risk of complications, coupled with appropriate and timely interventions, might help in reducing the risk of encountering premature mortality. The present study was design to address this specific issue.
Detailed description
Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria were recruited.
Diagnosis was confirmed on the basis of the Oral Glucose Tolerance Test (OGTT) or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl.
Anthropometric measurements were recorded, arterial pressure and vital parameters were registered, and blood samples were collected for routine analyses. Complete blood count, glucose, HbA1c, Serum Glutamic Oxaloacetic Transaminase (sGOT), Serum Glutamic Pyruvic Transaminase (sGPT), uric acid, were determined by standard techniques. Total and HDL cholesterol and triglycerides were assayed through the automated spectrophotometer, enzymatic colorimetric method, COBAS INTEGRA using commercial kits (Roche Diagnostics). Serum creatinine was measured by Jaffe' method, and estimated glomerular filtration rate (eGFR) was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Previous major acute CV events, including myocardial infarction, stroke, foot ulcer/gangrene/amputation and coronary, carotid and lower limb revascularisation, were adjudicated based on hospital discharge records.
At the end of the baseline visit, patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits, until death or until 31 December 2018. All-cause mortality was assessed by checking the vital status of study participants on 31 December 2018; to this aim, investigators interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
Incident major acute cardiovascular events were registered on the basis of clinical records every year; retinopathy onset was assessed by fundoscopy on a yearly basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neo-diagnosed type 2 diabetes | – | Other: standard treatmentsPatients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria.
Key inclusion criteria (3 listed)
- age ≥30 years
- personal history of known T2D lasting not more than six months
- diagnosis confirmed on the basis of the OGTT or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl
Key exclusion criteria (4 listed)
- longstanding disease duration
- type 1 diabetes
- diabetes secondary to steroid therapy
- active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard treatmentspatients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits | Other | Patients with neo-diagnosed type 2 diabetes |
Primary outcome
Number of participants who died during the study
Time frame: At 31 December 2018
The number of participants who died during the study was assessed by checking the vital status of study participants on 31 December 2018; to this aim, we interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
Incidence of cardiovascular disease
Time frame: At 31 December 2018
Incident major acute cardiovascular events were registered on the basis of clinical records every year
Incidence of microvascular complication
Time frame: At 31 December 2018
Retinopathy onset was assessed by fundoscopy on a yearly basis.
3 secondary outcomes
Change of renal function through study completion (an average of 5 year)
Time frame: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Change of blood glucose through study completion (an average of 5 year)
Time frame: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Change of HbA1c through study completion (an average of 5 year)
Time frame: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Background: PubMed 22079683Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.
- Background: PubMed 26510021Tancredi M, Rosengren A, Svensson AM, Kosiborod M, Pivodic A, Gudbjornsdottir S, Wedel H, Clements M, Dahlqvist S, Lind M. Excess Mortality among Persons with Type 2 Diabetes. N Engl J Med. 2015 Oct 29;373(18):1720-32. doi: 10.1056/NEJMoa1504347.
- Background: PubMed 25128274Gregg EW, Zhuo X, Cheng YJ, Albright AL, Narayan KM, Thompson TJ. Trends in lifetime risk and years of life lost due to diabetes in the USA, 1985-2011: a modelling study. Lancet Diabetes Endocrinol. 2014 Nov;2(11):867-74. doi: 10.1016/S2213-8587(14)70161-5. Epub 2014 Aug 12.
- Background: PubMed 31596048Ghouse J, Isaksen JL, Skov MW, Lind B, Svendsen JH, Kanters JK, Olesen MS, Holst AG, Nielsen JB. Effect of diabetes duration on the relationship between glycaemic control and risk of death in older adults with type 2 diabetes. Diabetes Obes Metab. 2020 Feb;22(2):231-242. doi: 10.1111/dom.13891. Epub 2019 Nov 18.
- Background: PubMed 24461345Gimeno Orna JA, Blasco Lamarca Y, Campos Gutierrez B, Molinero Herguedas E, Lou Arnal LM. [Morbidity and mortality cardiovascular risk in dependence of type 2 diabetes duration]. Clin Investig Arterioscler. 2014 May-Jun;26(3):122-30. doi: 10.1016/j.arteri.2013.11.010. Epub 2014 Jan 23. Spanish.
- Background: PubMed 29567074Herrington WG, Alegre-Diaz J, Wade R, Gnatiuc L, Ramirez-Reyes R, Hill M, Solano-Sanchez M, Baigent C, Lewington S, Collins R, Tapia-Conyer R, Peto R, Kuri-Morales P, Emberson JR. Effect of diabetes duration and glycaemic control on 14-year cause-specific mortality in Mexican adults: a blood-based prospective cohort study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):455-463. doi: 10.1016/S2213-8587(18)30050-0. Epub 2018 Mar 19.
- Background: PubMed 29473119Huo L, Magliano DJ, Ranciere F, Harding JL, Nanayakkara N, Shaw JE, Carstensen B. Impact of age at diagnosis and duration of type 2 diabetes on mortality in Australia 1997-2011. Diabetologia. 2018 May;61(5):1055-1063. doi: 10.1007/s00125-018-4544-z. Epub 2018 Feb 22.
- Background: PubMed 27881363Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.
- Background: PubMed 16936145Smith NL, Barzilay JI, Kronmal R, Lumley T, Enquobahrie D, Psaty BM. New-onset diabetes and risk of all-cause and cardiovascular mortality: the Cardiovascular Health Study. Diabetes Care. 2006 Sep;29(9):2012-7. doi: 10.2337/dc06-0574.
- Individual participant dataSharing planned: No
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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.
Anna Solini, MD, PhD principal investigator
University of Pisa
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 Type 2 Diabetes and Vascular Diseases, run by University of Pisa at 1 site in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 2020. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who died during the study (time frame: At 31 December 2018). The study lists 3 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 NCT04453605, which also lists 9 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 1 Jul 2020.