Type 2 Diabetes MellitusSUMMERNCT02311244
The Sapienza University Mortality and Morbidity Events Rate (SUMMER) Study in Diabetes
An observational study of Type 2 Diabetes Mellitus, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This observational study is aimed at identifying new molecular promoters of mortality (and morbidity) in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 5,139 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary care outpatients clinic
Who may be able to join
- Type 2 diabetes mellitus
Who cannot join
- Severe psychiatric illnesses
- End-stage renal disease and dialysis
- Cirrhosis
- Any active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sapienza University Mortality and Morbidity Events Rate (SUMMER) Study in Diabetes: Identification of New Molecular Promoters of Mortality and Morbidity in Patients With Type 2 Diabetes Mellitus
This observational study is aimed at identifying new molecular promoters of mortality (and morbidity) in patients with type 2 diabetes mellitus (T2DM).
Read the detailed description
Background Mortality rate of diabetic patients is about twice as much that of non-diabetic individuals of similar age; this makes diabetes a leading risk factor for mortality, especially of cardiovascular origin, which accounts for 2.9 million global events yearly. Such scenario is expected to further deteriorate, given that the prevalence of type 2 diabetes mellitus (T2DM), by far the most common form of diabetes comprising more than 90% of all diabetic individuals, is increasing worldwide. Predicting such devastating event is, therefore, urgently needed in order to target aggressive prevention strategies in high risk T2DM patients.
Aims This observational study is aimed at identifying new molecular promoters of all-cause mortality in patients with T2DM.
Secondary endpoints are to identify in these individuals molecular markers of
- cardiovascular mortality;
- myocardial infarction;
- stroke;
- dialysis.
Other pre-specified endpoints are to assess in these subjects:
- LADA;
- severe hypoglycemic episodes;
- revascularization procedures;
- hospitalization for heart failure;
- other co-morbidities (cancer - at follow-up only, liver disease, chronic obstructive pulmonary disease, autoimmune and endocrine disorders, other - non-diabetic - renal diseases, fractures, cognitive impairment).
Patients A total of 5,000 patients with T2DM of both sexes will be recruited. Measures The following parameters will be recorded as exposure variables at baseline.
- Age, BMI, waist circumference, systolic and diastolic pressure;
- Lifestyle habits, including diet, physical activity (both by validated questionnaires) and smoking.
- Menopausal state (for women).
- Family history of diabetes (3 consecutive generations).
- Family history of cardiovascular disease (first degree relatives).
- Diabetes duration.
- Severe (requiring assistance) hypoglycemic episodes (per year).
- Myocardial infarction, stroke, ulcer/gangrene/amputation, coronary and peripheral revascularization, hospitalization for heart failure, dialysis (at follow-up only).
- Glucose, HbA1c, creatinine, uric acid, total and HDL cholesterol, triglycerides, high sensitive C reactive protein, testosterone, Vitamin D, uric acid levels, white blood cells counting, urinary albumin creatinine ratio (ACR)
- Current glucose-, lipid-, blood pressure-lowering and anti-platelet or anti-coagulant treatment.
- Other relevant treatments (steroids, NSAIDs, immunomodulators, androgens, estrogens, anti-fracturative therapy).
- Main co-morbidities (cancer, chronic liver disease, chronic obstructive pulmonary disease, autoimmune and endocrine disorders, other - non-diabetic - renal diseases, fractures, cognitive impairment).
The following parameters will be assessed at baseline only:
- GADAs (by a radiobinding assay using in vitro translated [35S] methionine-labelled GAD65) and IA-2 antibodies (by radioimmunoprecipitation assays) to identify subjects with LADA.
- Genomic (common and rare variants in genes of interest according to a pathway-centric approach by means of Affymetrix platforms), transcriptomic (differential levels of mRNA by GeneChip Human Gene 1.0 ST Array from Affymetrix) and metabolomic by a combination of ultra-pressure liquid chromatography and gas chromatography coupled to mass spectrometry) analysis.
Measurements of testosterone, Vitamin D, GADAs and IA-2 antibodies as well as gnomic, transcriptomic and metabolomic analysis will be centralized.
Time schedule Recruitment of patients will last approximately 3 years. The enrolled patients will be followed for at least 5 years with yearly visits and telephone calls or consultation of death records in case of drop-out for unknown reasons.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- All-cause mortality, Cardiovascular mortality, Myocardial infarction, Stroke, Dialysis
- Medical subject headings
- Diabetes Mellitus, Type 2, Myocardial Infarction, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all-cause deaths
Number of participants who die for all causes and time of occurrence of such events
Measured: 5 years
Secondary outcomes (4)
Number of cardiovascular deaths
Number of participants who die for cardiovascular causes and time of occurrence of such events
Measured: 5 years
Number of subjects with myocardial infarction
Number of participants who develop myocardial infarction and time of occurrence of such events
Measured: 5 years
Number of subjects with stroke
Number of participants who develop stroke and time of occurrence of such events
Measured: 5 years
Number of subjects entering dialysis
Number of participants who enter dialysis and time of occurrence of such events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2020
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Ospedale Sandro Pertini, Roma, Azienda Ospedaliera San Camillo Forlanini, University of Cagliari, Casa Sollievo della Sofferenza IRCCS
- Responsible party
- Principal investigator, Vincenzo Trischitta, University of Roma La Sapienza
- Investigators
- Vincenzo Trischitta, MD, Principal investigator, University of Roma La SapienzaGiuseppe Pugliese, MD, PhD, Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311244
- Sponsor's protocol ID
- URomLS-01-2014
- Acronym
- SUMMER
- Status last verified
- May 2023
- First submitted
- 24 Nov 2014
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.
PubMed 21366474Roglic G, Unwin N, Bennett PH, Mathers C, Tuomilehto J, Nag S, Connolly V, King H. The burden of mortality attributable to diabetes: realistic estimates for the year 2000. Diabetes Care. 2005 Sep;28(9):2130-5. doi: 10.2337/diacare.28.9.2130.
PubMed 16123478De Cosmo S, Copetti M, Lamacchia O, Fontana A, Massa M, Morini E, Pacilli A, Fariello S, Palena A, Rauseo A, Viti R, Di Paola R, Menzaghi C, Cignarelli M, Pellegrini F, Trischitta V. Development and validation of a predicting model of all-cause mortality in patients with type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2830-5. doi: 10.2337/dc12-1906. Epub 2013 May 1.
PubMed 23637348Hong Kong Diabetes Registry; Yang X, So WY, Tong PC, Ma RC, Kong AP, Lam CW, Ho CS, Cockram CS, Ko GT, Chow CC, Wong VC, Chan JC. Development and validation of an all-cause mortality risk score in type 2 diabetes. Arch Intern Med. 2008 Mar 10;168(5):451-7. doi: 10.1001/archinte.168.5.451.
PubMed 18332288Wells BJ, Jain A, Arrigain S, Yu C, Rosenkrans WA Jr, Kattan MW. Predicting 6-year mortality risk in patients with type 2 diabetes. Diabetes Care. 2008 Dec;31(12):2301-6. doi: 10.2337/dc08-1047. Epub 2008 Sep 22.
PubMed 18809629McEwen LN, Karter AJ, Waitzfelder BE, Crosson JC, Marrero DG, Mangione CM, Herman WH. Predictors of mortality over 8 years in type 2 diabetic patients: Translating Research Into Action for Diabetes (TRIAD). Diabetes Care. 2012 Jun;35(6):1301-9. doi: 10.2337/dc11-2281. Epub 2012 Mar 19.
PubMed 22432119Maddaloni E, Coraggio L, Amendolara R, Baroni MG, Cavallo MG, Copetti M, Cossu E, D'Angelo P, D'Onofrio L, Cosmo S, Leonetti F, Morano S, Morviducci L, Napoli N, Prudente S, Pugliese G, Park K, Holman RR, Trischitta V, Buzzetti R; SUMMER Study in Diabetes Group. Association of osteocalcin, osteoprotegerin, and osteopontin with cardiovascular disease and retinopathy in type 2 diabetes. Diabetes Metab Res Rev. 2023 Jul;39(5):e3632. doi: 10.1002/dmrr.3632. Epub 2023 Mar 20.
PubMed 36880127Barchetta I, Capoccia D, Baroni MG, Buzzetti R, Cavallo MG, De Cosmo S, Leonetti F, Leotta S, Morano S, Morviducci L, Prudente S, Pugliese G, Trischitta V; SUMMER Study in Diabetes Group. The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes": Study protocol. Nutr Metab Cardiovasc Dis. 2016 Feb;26(2):103-8. doi: 10.1016/j.numecd.2015.09.009. Epub 2015 Oct 9.
PubMed 26698225
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sapienza University Mortality and Morbidity Events Rate (SUMMER) Study in Diabetes: Identification of New Molecular Promoters of Mortality and Morbidity in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02311244
- Acronym / sponsor ID
- SUMMER / URomLS-01-2014
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- All-cause mortality, Cardiovascular mortality, Myocardial infarction, Stroke, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,139 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Ospedale Sandro Pertini, Roma, Azienda Ospedaliera San Camillo Forlanini, University of Cagliari, Casa Sollievo della Sofferenza IRCCS
- Study start
- Jan 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 8 Dec 2014 (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.
This observational study is aimed at identifying new molecular promoters of mortality (and morbidity) in patients with type 2 diabetes mellitus (T2DM).
Detailed description
Background Mortality rate of diabetic patients is about twice as much that of non-diabetic individuals of similar age; this makes diabetes a leading risk factor for mortality, especially of cardiovascular origin, which accounts for 2.9 million global events yearly. Such scenario is expected to further deteriorate, given that the prevalence of type 2 diabetes mellitus (T2DM), by far the most common form of diabetes comprising more than 90% of all diabetic individuals, is increasing worldwide. Predicting such devastating event is, therefore, urgently needed in order to target aggressive prevention strategies in high risk T2DM patients.
Aims This observational study is aimed at identifying new molecular promoters of all-cause mortality in patients with T2DM.
Secondary endpoints are to identify in these individuals molecular markers of
- cardiovascular mortality;
- myocardial infarction;
- stroke;
- dialysis.
Other pre-specified endpoints are to assess in these subjects:
- LADA;
- severe hypoglycemic episodes;
- revascularization procedures;
- hospitalization for heart failure;
- other co-morbidities (cancer - at follow-up only, liver disease, chronic obstructive pulmonary disease, autoimmune and endocrine disorders, other - non-diabetic - renal diseases, fractures, cognitive impairment).
Patients A total of 5,000 patients with T2DM of both sexes will be recruited. Measures The following parameters will be recorded as exposure variables at baseline.
- Age, BMI, waist circumference, systolic and diastolic pressure;
- Lifestyle habits, including diet, physical activity (both by validated questionnaires) and smoking.
- Menopausal state (for women).
- Family history of diabetes (3 consecutive generations).
- Family history of cardiovascular disease (first degree relatives).
- Diabetes duration.
- Severe (requiring assistance) hypoglycemic episodes (per year).
- Myocardial infarction, stroke, ulcer/gangrene/amputation, coronary and peripheral revascularization, hospitalization for heart failure, dialysis (at follow-up only).
- Glucose, HbA1c, creatinine, uric acid, total and HDL cholesterol, triglycerides, high sensitive C reactive protein, testosterone, Vitamin D, uric acid levels, white blood cells counting, urinary albumin creatinine ratio (ACR)
- Current glucose-, lipid-, blood pressure-lowering and anti-platelet or anti-coagulant treatment.
- Other relevant treatments (steroids, NSAIDs, immunomodulators, androgens, estrogens, anti-fracturative therapy).
- Main co-morbidities (cancer, chronic liver disease, chronic obstructive pulmonary disease, autoimmune and endocrine disorders, other - non-diabetic - renal diseases, fractures, cognitive impairment).
The following parameters will be assessed at baseline only:
- GADAs (by a radiobinding assay using in vitro translated [35S] methionine-labelled GAD65) and IA-2 antibodies (by radioimmunoprecipitation assays) to identify subjects with LADA.
- Genomic (common and rare variants in genes of interest according to a pathway-centric approach by means of Affymetrix platforms), transcriptomic (differential levels of mRNA by GeneChip Human Gene 1.0 ST Array from Affymetrix) and metabolomic by a combination of ultra-pressure liquid chromatography and gas chromatography coupled to mass spectrometry) analysis.
Measurements of testosterone, Vitamin D, GADAs and IA-2 antibodies as well as gnomic, transcriptomic and metabolomic analysis will be centralized.
Time schedule Recruitment of patients will last approximately 3 years. The enrolled patients will be followed for at least 5 years with yearly visits and telephone calls or consultation of death records in case of drop-out for unknown reasons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care outpatients clinic
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Severe psychiatric illnesses
- End-stage renal disease and dialysis
- Cirrhosis
- Any 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.
Primary outcome
Number of all-cause deaths
Time frame: 5 years
Number of participants who die for all causes and time of occurrence of such events
4 secondary outcomes
Number of cardiovascular deaths
Time frame: 5 years
Number of subjects with myocardial infarction
Time frame: 5 years
Number of subjects with stroke
Time frame: 5 years
Number of subjects entering dialysis
Time frame: 5 years
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 12 May 2023.
- Background: PubMed 21366474Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.
- Background: PubMed 16123478Roglic G, Unwin N, Bennett PH, Mathers C, Tuomilehto J, Nag S, Connolly V, King H. The burden of mortality attributable to diabetes: realistic estimates for the year 2000. Diabetes Care. 2005 Sep;28(9):2130-5. doi: 10.2337/diacare.28.9.2130.
- Background: PubMed 23637348De Cosmo S, Copetti M, Lamacchia O, Fontana A, Massa M, Morini E, Pacilli A, Fariello S, Palena A, Rauseo A, Viti R, Di Paola R, Menzaghi C, Cignarelli M, Pellegrini F, Trischitta V. Development and validation of a predicting model of all-cause mortality in patients with type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2830-5. doi: 10.2337/dc12-1906. Epub 2013 May 1.
- Background: PubMed 18332288Hong Kong Diabetes Registry; Yang X, So WY, Tong PC, Ma RC, Kong AP, Lam CW, Ho CS, Cockram CS, Ko GT, Chow CC, Wong VC, Chan JC. Development and validation of an all-cause mortality risk score in type 2 diabetes. Arch Intern Med. 2008 Mar 10;168(5):451-7. doi: 10.1001/archinte.168.5.451.
- Background: PubMed 18809629Wells BJ, Jain A, Arrigain S, Yu C, Rosenkrans WA Jr, Kattan MW. Predicting 6-year mortality risk in patients with type 2 diabetes. Diabetes Care. 2008 Dec;31(12):2301-6. doi: 10.2337/dc08-1047. Epub 2008 Sep 22.
- Background: PubMed 22432119McEwen LN, Karter AJ, Waitzfelder BE, Crosson JC, Marrero DG, Mangione CM, Herman WH. Predictors of mortality over 8 years in type 2 diabetic patients: Translating Research Into Action for Diabetes (TRIAD). Diabetes Care. 2012 Jun;35(6):1301-9. doi: 10.2337/dc11-2281. Epub 2012 Mar 19.
- Derived from this study: PubMed 36880127Maddaloni E, Coraggio L, Amendolara R, Baroni MG, Cavallo MG, Copetti M, Cossu E, D'Angelo P, D'Onofrio L, Cosmo S, Leonetti F, Morano S, Morviducci L, Napoli N, Prudente S, Pugliese G, Park K, Holman RR, Trischitta V, Buzzetti R; SUMMER Study in Diabetes Group. Association of osteocalcin, osteoprotegerin, and osteopontin with cardiovascular disease and retinopathy in type 2 diabetes. Diabetes Metab Res Rev. 2023 Jul;39(5):e3632. doi: 10.1002/dmrr.3632. Epub 2023 Mar 20.
- Derived from this study: PubMed 26698225Barchetta I, Capoccia D, Baroni MG, Buzzetti R, Cavallo MG, De Cosmo S, Leonetti F, Leotta S, Morano S, Morviducci L, Prudente S, Pugliese G, Trischitta V; SUMMER Study in Diabetes Group. The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes": Study protocol. Nutr Metab Cardiovasc Dis. 2016 Feb;26(2):103-8. doi: 10.1016/j.numecd.2015.09.009. Epub 2015 Oct 9.
- Study webpageLink provided by the sponsor.
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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.
Vincenzo Trischitta, MD principal investigator
University of Roma La Sapienza
Giuseppe Pugliese, MD, PhD study director
University of Roma La Sapienza
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 Mellitus, run by University of Roma La Sapienza 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 1 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 12 May 2023. 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 all-cause deaths (time frame: 5 years). 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 NCT02311244, which also lists 8 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 12 May 2023.