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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311244
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Campus Bio-Medico University
Ospedale Sandro Pertini, Roma
Azienda Ospedaliera San Camillo Forlanini
University of Cagliari
Casa Sollievo della Sofferenza IRCCS
Information provided by (Responsible Party):
Vincenzo Trischitta, University of Roma La Sapienza

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

Condition or disease
Type 2 Diabetes Mellitus

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of all-cause deaths [ Time Frame: 5 years ]
    Number of participants who die for all causes and time of occurrence of such events


Secondary Outcome Measures :
  1. Number of cardiovascular deaths [ Time Frame: 5 years ]
    Number of participants who die for cardiovascular causes and time of occurrence of such events

  2. Number of subjects with myocardial infarction [ Time Frame: 5 years ]
    Number of participants who develop myocardial infarction and time of occurrence of such events

  3. Number of subjects with stroke [ Time Frame: 5 years ]
    Number of participants who develop stroke and time of occurrence of such events

  4. Number of subjects entering dialysis [ Time Frame: 5 years ]
    Number of participants who enter dialysis and time of occurrence of such events


Biospecimen Retention:   Samples With DNA
Serum and urine


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Secondary care outpatients clinic
Criteria

Inclusion Criteria:

Type 2 diabetes mellitus

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311244


Contacts
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Contact: Vincenzo Trischitta, MD +390644160534 vincenzo.trischitta@uniroma1.it
Contact: Giuseppe Pugliese, MD, PhD +390633775440 giuseppe.pugliese@uniroma1.it

Locations
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Italy
University of Roma La Sapienza Recruiting
Rome, RM, Italy, 00161
Contact: Vincenzo Trischitta, MD    +390644160534    vincenzo.trischitta@uniroma1.it   
Contact: Giuseppe Pugliese, MD, PhD    +390633775440    giuseppe.pugliese@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Campus Bio-Medico University
Ospedale Sandro Pertini, Roma
Azienda Ospedaliera San Camillo Forlanini
University of Cagliari
Casa Sollievo della Sofferenza IRCCS
Investigators
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Principal Investigator: Vincenzo Trischitta, MD University of Roma La Sapienza
Study Director: Giuseppe Pugliese, MD, PhD University of Roma La Sapienza
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vincenzo Trischitta, MD, Professor of Endocrinology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02311244    
Other Study ID Numbers: URomLS-01-2014
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Keywords provided by Vincenzo Trischitta, University of Roma La Sapienza:
All-cause mortality
Cardiovascular mortality
Myocardial infarction
Stroke
Dialysis
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases