The Sapienza University Mortality and Morbidity Events Rate (SUMMER) Study in Diabetes

NCT02311244 | Completed

• 1 other identifier: URomLS-01-2014
• Study Type: observational
• Target: 5,139
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is aimed at identifying new molecular promoters of mortality (and morbidity) in patients with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus

Keywords

All-cause mortality; Cardiovascular mortality; Myocardial infarction; Stroke; Dialysis

Outcome Measures

Primary Outcomes (1)

• Number of all-cause deaths

  Number of participants who die for all causes and time of occurrence of such events

  5 years

Secondary Outcomes (4)

• Number of cardiovascular deaths

  5 years

• Number of subjects with myocardial infarction

  5 years

• Number of subjects with stroke

  5 years

• Number of subjects entering dialysis

  5 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Secondary care outpatients clinic

You may qualify if:

• Type 2 diabetes mellitus

You may not qualify if:

• Severe psychiatric illnesses
• End-stage renal disease and dialysis
• Cirrhosis
• Any active cancer

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Campus Bio-Medico University: collaborator
• Ospedale Sandro Pertini, Roma: collaborator
• Azienda Ospedaliera San Camillo Forlanini: collaborator
• University of Cagliari: collaborator
• Casa Sollievo della Sofferenza IRCCS: collaborator

Study Sites (1)

University of Roma La Sapienza

Rome, RM, 00161, Italy

Location

Related Publications (8)

• 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.

  PMID: 21366474 BACKGROUND

• Roglic 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.

  PMID: 16123478 BACKGROUND

• De 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.

  PMID: 23637348 BACKGROUND

• Hong 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.

  PMID: 18332288 BACKGROUND

• Wells 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.

  PMID: 18809629 BACKGROUND

• McEwen 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.

  PMID: 22432119 BACKGROUND

• Maddaloni 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.

  PMID: 36880127 DERIVED

• Barchetta 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.

  PMID: 26698225 DERIVED

Related Links

• Study webpage

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vincenzo Trischitta, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

• Giuseppe Pugliese, MD, PhD

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Endocrinology

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 8, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

IT (1)