Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity
Conditions: Sarcopenia, Obesity, Diabetes Mellitus, Type 2
Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

REGIONE PUGLIA
AZIENDA OSPEDALIERO UNIVERSITARIA
Ospedale Policlinico Consorziale – Bari
U.O. Complessa di ENDOCRINOLOGIA
Dipartimentodi Medicina di Precisione e Rigenerativa e
AreaJonica
Sezione diMedicinaInterna,Endocrinologia,Andrologia e
MalattieMetaboliche
Direttore: Prof. Francesco Giorgino
INFORMED CONSENT ON CONSERVATION OF BIOLOGICAL MATERIAL
Version 1 of 27.12.2022
I, the undersigned . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Born in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Resident in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Province . . . . . . . . . . . . . . . . . . . . ZIP/CAP . . . . . . . . . . . . . . . . . . . . . . .
Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Phone number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
After being informed that:
·
The biological material retrieved can be conserved at the laboratory
·
The biological material retrieved may be utilized for further investigations at exclusive research
purpose, never for direct profit.
·
As per the law D.L. N° 196/03, anonymity and privacy will be guaranteed, and privacy on the origin of
the sample and on genetic data obtained will be maintained.
·
I will express the will not to be informed on the results of further investigations (as per art. 10 comma
2 of the Convenzione sui diritti dell’Uomo e sulla Biomedicina – Oviedo 4 Aprile 1997, ratified in the
law 28 Marzo 2001, n° 145).
·
The suitability of the sample will be kept at any cost; nevertheless, the Center declines the
responsibility for any damage o accidents that may happen.
·
The genetic data acquired may be conserved and possibly used for the sole aim of research.
·
In any moment I will be able to communicate a change of mind about what I declared; in which case,
the sample and the accompaning data will be erased and will not be used for further research.
Telefoni & Fax:
Direzione
0805478689
DIVISIONE CLINICA
Segreteria Direzione     0805592308                    Medicheria                 0805592314
Segreteria Clinica          0805594174                    Sala Medici                0805592495
Fax                                  0805478783                    Reparti Degenza        0805592688
Prenotazioni              0805592490
Indirizzo:
Piazza Giulio Cesare, 11 – Padiglione “V. Chini”
70124 BARI
DAY HOSPITAL
Prenotazioni
0805592490
LABORATORI
Diagnostica           0805592640
Ricerca                  0805594186
E-mail:
istituto.segreteria@endo.uniba.it
AMBULATORI
Malattie Endocrine (Tiroide, Paratiroidi,
Surrene, Ipofisi)
Nutrizione Clinica
Diabete Mellito
Andrologia Medica
Prenotazioni
0805592156

REGIONE PUGLIA
AZIENDA OSPEDALIERO UNIVERSITARIA
Ospedale Policlinico Consorziale – Bari
U.O. Complessa di ENDOCRINOLOGIA
Dipartimentodi Medicina di Precisione e Rigenerativa e
AreaJonica
Sezione diMedicinaInterna,Endocrinologia,Andrologia e
MalattieMetaboliche
Direttore: Prof. Francesco Giorgino
DECLARES:
 Authorize
 Authorize
 Authorize
 Want
 Not authorize
 Not authorize
 Not authorize
 Do not want
the biological material conservation
the exclusive use of materal for diagnosis
and/or research
the conservation of genetic data and the use for
research purposes
to be informed on results about health coming
from these studies and researches
Date ____________________
Signature ______________________
The undersigned, Prof./Dr. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , guarantees the respect
of the previous declarations.
Any future test will be done after authorization by the Ethics Committee.
Date ____________________
Signature ______________________
Telefoni & Fax:
Direzione
0805478689
DIVISIONE CLINICA
Segreteria Direzione     0805592308                    Medicheria                 0805592314
Segreteria Clinica          0805594174                    Sala Medici                0805592495
Fax                                  0805478783                    Reparti Degenza        0805592688
Prenotazioni              0805592490
Indirizzo:
Piazza Giulio Cesare, 11 – Padiglione “V. Chini”
70124 BARI
DAY HOSPITAL
Prenotazioni
0805592490
LABORATORI
Diagnostica           0805592640
Ricerca                  0805594186
E-mail:
istituto.segreteria@endo.uniba.it
AMBULATORI
Malattie Endocrine (Tiroide, Paratiroidi,
Surrene, Ipofisi)
Nutrizione Clinica
Diabete Mellito
Andrologia Medica
Prenotazioni
0805592156

REGIONE PUGLIA
AZIENDA OSPEDALIERO UNIVERSITARIA
Ospedale Policlinico Consorziale – Bari
U.O. Complessa di ENDOCRINOLOGIA
Dipartimentodi Medicina di Precisione e Rigenerativa e
AreaJonica
Sezione diMedicinaInterna,Endocrinologia,Andrologia e
MalattieMetaboliche
Direttore: Prof. Francesco Giorgino
INFORMATION FOR THE PATIENT AND INFORMED CONSENT
Version 1 of 27/12/2022
TITLE: Relationship Between Parameters of Glycemic Control and Irisin Levels in
Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic
Obesity
PRINCIPAL INVESTIGATOR: Prof. Francesco Giorgino
PATIENT NAME: _________________________________________________________
Dear Sir/Madame,
We invite you to participate in a study on biological material about the evaluation of blood irisin levels.
The study is done at Azienda Ospedaliero-Universitaria Policlinico "Consorziale" in Bari. The study
includes a venous sampling from the antecubital vein for research purposes.
PURPOSE OF THE STUDY
The study proposes to understand if, and in which magnitude, body composition and glycemic control are
correlated to irisin levels.
It is known, indeed, that irisin levels are lower in people with fewer muscle mass (condition known as
sarcopenia) and in patients with Type 2 Diabetes Mellitus.
Finding a significative correlation may, in the future, provide basis for studies in which irisin might be
used as a therapy to increase the muscle mass and/or to improve the glycemic control. If this, then, will
demonstrate effective, we will have yet another weapon to improve the wellness of patients affected by
sarcopenia and Type 2 Diabetes Mellitus.

REGIONE PUGLIA
AZIENDA OSPEDALIERO UNIVERSITARIA
Ospedale Policlinico Consorziale – Bari
U.O. Complessa di ENDOCRINOLOGIA
Dipartimentodi Medicina di Precisione e Rigenerativa e
AreaJonica
Sezione diMedicinaInterna,Endocrinologia,Andrologia e
MalattieMetaboliche
Direttore: Prof. Francesco Giorgino
PATIENT PARTICIPATION
The study will be conducted on the about 3000 patients affected by Type 2 Diabetes Mellitus that are
routinely visited every year in the Diabetology clinic of the Policlinico di Bari.
Your participation in the study consists in your consent to the venous sampling from the antecubital vein,
in the use of the sample for the study in object, and in the use of the data that are routinely detected to
check your glycemic status and other cardiovascular risk factors (biochemical exams and anthropometric
data).
These data will be utilized for a statistic analysis that will allow to obtain the wanted information, without
interfering with your privacy. The data that will be retrieved will be known to your doctor and to the
authorized personnel; any other person will not be able to know your name due to a cyber protection
mechanism of the database.
RESPONSIBILITY AND PROCEDURES
If you will participate in this study, the above data from the visit(s) that you routinely undergo will be
reported on a cyber record and on your outpatient record. Your doctor and the authorized personnel will
be the only ones to have access to your personal data (name, surname, place and date of birth, place of
residence and phone number) on the cyber record, and they will as well be the only ones with access to
your outpatient record.
RISKS CONNECTED TO THE VENOUS SAMPLING
The physical risks and the disturbances related to the blood sampling are identical to the ones of any type
of venipuncture, that is the possibility of small local bruises and local irritation
POSSIBLE BENEFITS
You will not have any direct benefit from participating in this study. Nevertheless, this study might
contribute to increase our knowledge about Type 2 Diabetes Mellitus and favour the development of
therapeutic patient-specific strategies.
COSTS
You will not incur in any adjunctive payment because the visits, the laboratory analyses and the
instrumental analyses done for the study are the same that you undergo for routine visits, according to
good clinical practice, while experiments done on the blood sample will be carried out at our Laboratory
of biomedical research in Endocrinology and Metabolism of the Department of Precision and
Regenerative Medicine and Jonic Area (DiMePRe-J) and the relative costs will be on the university funds

REGIONE PUGLIA
AZIENDA OSPEDALIERO UNIVERSITARIA
Ospedale Policlinico Consorziale – Bari
U.O. Complessa di ENDOCRINOLOGIA
Dipartimentodi Medicina di Precisione e Rigenerativa e
AreaJonica
Sezione diMedicinaInterna,Endocrinologia,Andrologia e
MalattieMetaboliche
Direttore: Prof. Francesco Giorgino
of the above mentioned Department, Internal Medicine, Endocrinology, Andrology and Metabolic
Diseases section.
INSURANCE
As there will not be any deviation, due to the study, from normal procedures that you undergo in your
periodic visits, no insurance is needed.
ALTERNATIVES TO PARTECIPATION
You are not forced to participate in this study to receive an optimal treatment for your pathology.
VOLUNTARY PARTICIPATION/WITHDRAWAL
Your participation in this study is completely voluntary. You can decide not to be involved or, if you decide
to participate, you can later decide to withdraw, without the need of explanations. Accepting to participate
in this study doesn’t force you to participate in future studies. If you decide not to participate or to
withdraw you will not be penalized in any way, nor you will lose any of the benefits you have the right
to.
QUESTIONS
You are encouraged to ask questions. If you have any doubt about the study, we encourage your to speak
about it to your doctos who, if needed, will get you in touch with the study head, Prof. Francesco Giorgino.
Please don’t sign this module unless you had the opportunity to ask questions and obtain satisfying
answers. If you accept to participate in this study you will receive a copy of this informed consent module
signed for your private documentation.
Date:_________________
Name and surname of the investigator: _________________________
The investigator: _______________________

REGIONE PUGLIA
AZIENDA OSPEDALIERO UNIVERSITARIA
Ospedale Policlinico Consorziale – Bari
U.O. Complessa di ENDOCRINOLOGIA
Dipartimentodi Medicina di Precisione e Rigenerativa e
AreaJonica
Sezione diMedicinaInterna,Endocrinologia,Andrologia e
MalattieMetaboliche
Direttore: Prof. Francesco Giorgino
TITLE: Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With
Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity
INFORMED CONSENT
I read and understood the information in this module of informed consent (or they have been read to me). By signing this
module I certify that this study has been explained to me and Dr____________ answered to my questions. I accept to
participate in the study. By signing this consent I don’t give up any of my rights as a patient in a study on human biological
material. I acknowledge that participation is completely voluntary and that I can withdraw from the study at any moment
without having to explain myself and without osing my benefits.
According to the law DLgv 196/03, I acccept that personal data about my pathology collected for the above mentioned
study will be saved as encoded by regulatory authorities for scientific analysis and eventual publications
I consent that representatives form regulatory authorities have confidential access to my medical data, to ensure correct
management of the study.
Name of the patient: ____________________________________________________
Signature of the patient: ___________________________________
Date: ___________________
Certification of the person who explained the informed consent
I discussed the above points with the patient. It is my opinion that the patient understands the risks, benefits and the
procedures of this study.
Signature of the person who explains the informed consent
_______________________________________________
Date ___________________
------------------------------------------------------To utilize if applicable -------------------------------------------------------
If this consent module is read to the patient because he can’t read, it is required for an impartial witness not involved in the study or with the investigator to
sign the following declaration:
I confirm that the information in this module of informed consent and any other written information have been accurately
explained and apparently understood by the patient. The patient freely agrees to participate in this study.
Signature of an impartial witness _________________________
Date ____________________