SarcopeniaNCT05908812
Relationship Between Glycemic Control and Irisin in Type 2 Diabetic Patients With Sarcopenic or Non-sarcopenic Obesity
An observational study of Sarcopenia and Obesity, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
The goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Obesity, Diabetes Mellitus, Type 2
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 31 Jan 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from our Center's patients. A physician will screen the eligible patients from the automatic search on the database from the program Smart Digital Clinic.
Who may be able to join
- Diabetes mellitus type 2 diagnosed less than 10 years before
- age >60 years
- BMI (Body Mass Index) >30 kg/m2
- eGFR (estimated Glomerular Filtration Rate) >30 ml/min
- On stable antidiabetic therapy for at least 3 months
Who cannot join
- Insulin or insulin secretagogues use
- Diabetes mellitus type 1, previous diabetic ketoacidosis
- Neuromuscular diseases
- Endocrinopathies that may cause myopathies (hypercortisolism, GH [growth hormone] deficiency, acromegaly, adrenal insufficiency, partial hypopituitarism or panhypopituitarism, male hypogonadism, hyperparathyroidism, hypoparathyroidism)
- Severe vit. D deficiency (<12 ng/ml)
- Hemoglobinopathies
Show all 11Show fewer
- Prolonged immobilization
- Pathologies with fluid retention (heart failure with NYHA [New York Heart Association] class III/IV, severe renal insufficiency, hepatic insufficiency)
- Active tumors in the past 5 years
- Severe arthritis of the knee or hip
- Pacemaker wearer
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico di Bari
Bari, 70124
Francesco Giorgino, MD, PhD, +390805593522, francesco.giorgino@uniba.it
About this study
Official title: Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity
The goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity.
The main questions it aims to answer are:
Is glycemic control worse in diabetic patients with sarcopenic obesity? Are irisin levels higher in patients with non-sarcopenic obesity?
Participants will be asked to:
- Fill in three questionaries on lifestyle
- Perform two physical performance tests
The investigators will collect the following data:
- Anthropometric measurements
- Body composition by bioelectrical impedance analysis.
- Results of routine blood analyses
- Irisin levels by drawing a vial of blood from the antecubital vein
Read the detailed description
Patients will be enrolled from our Diabetology Center. Eligible patients will be contacted by phone to be informed of the procedures and to schedule the visit.
The patients will come to the visit bringing the blood analyses they usually bring for the routine diabetologic visit; they will also be fasting for at least 3 hours, and abstaining from smoking and physical activity since the day before. All visits will be performed in the afternoon, at about 4-6 p.m.
Participants will be asked to:
- Fill in three questionaries (SARC-F [Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire], IPAQ-EIT [International Physical Activity Questionnaire validated in the Elderly Italian population], MEDI-LITE [Adherence to the Mediterranean diet questionnaire])
- Perform two physical performance tests (5-times chair stand test and handgrip test).
Anthropometric measurements will be assessed; body composition will be evaluated by bioelectrical impedance analysis. A venous blood draw will be executed for evaluation of irisin levels after signing a written consent form.
- Conditions
- Sarcopenia, Obesity, Diabetes Mellitus, Type 2
- Keywords
- Irisin protein, Hand Strength [E01.370.600.425.500], Glycated Hemoglobin [D23.946.381.625.500.250]
- Medical subject headings
- Sarcopenia, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic obesity | BMI>30, bioelectric impedance positive for sarcopenic obesity (FM% [fat mass percentage] female >43%, male >31% AND SMM/W [skeletal muscle mass/weight] female <28%, male <37%), any one of the physical performance test positive (5-times chair stand test >17 s OR handgrip strength test <35,5 kg for males, <20 kg for females). | |
| Non-sarcopenic obesity | BMI>30, bioelectric impedance negative for sarcopenic obesity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity
Differences in glycated hemoglobin or in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) in patients with sarcopenic obesity vs non-sarcopenic obesity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Giorgino, MD, PhD, Principal investigator, Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908812
- Sponsor's protocol ID
- 0023237|08/03/2023
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23.
PubMed 35196654Shoukry A, Shalaby SM, El-Arabi Bdeer S, Mahmoud AA, Mousa MM, Khalifa A. Circulating serum irisin levels in obesity and type 2 diabetes mellitus. IUBMB Life. 2016 Jul;68(7):544-56. doi: 10.1002/iub.1511. Epub 2016 May 24.
PubMed 27220658Oguz A, Sahin M, Tuzun D, Kurutas EB, Ulgen C, Bozkus O, Gul K. Irisin is a predictor of sarcopenic obesity in type 2 diabetes mellitus: A cross-sectional study. Medicine (Baltimore). 2021 Jul 2;100(26):e26529. doi: 10.1097/MD.0000000000026529.
PubMed 34190188
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT05908812
- Acronym / sponsor ID
- 0023237|08/03/2023
- Conditions
- Sarcopenia, Obesity, Diabetes Mellitus, Type 2
- Keywords
- Irisin protein, Hand Strength [E01.370.600.425.500], Glycated Hemoglobin [D23.946.381.625.500.250]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 18 Jun 2023 (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.
The goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity.
The main questions it aims to answer are:
Is glycemic control worse in diabetic patients with sarcopenic obesity? Are irisin levels higher in patients with non-sarcopenic obesity?
Participants will be asked to:
- Fill in three questionaries on lifestyle
- Perform two physical performance tests
The investigators will collect the following data:
- Anthropometric measurements
- Body composition by bioelectrical impedance analysis.
- Results of routine blood analyses
- Irisin levels by drawing a vial of blood from the antecubital vein
Detailed description
Patients will be enrolled from our Diabetology Center. Eligible patients will be contacted by phone to be informed of the procedures and to schedule the visit.
The patients will come to the visit bringing the blood analyses they usually bring for the routine diabetologic visit; they will also be fasting for at least 3 hours, and abstaining from smoking and physical activity since the day before. All visits will be performed in the afternoon, at about 4-6 p.m.
Participants will be asked to:
- Fill in three questionaries (SARC-F [Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire], IPAQ-EIT [International Physical Activity Questionnaire validated in the Elderly Italian population], MEDI-LITE [Adherence to the Mediterranean diet questionnaire])
- Perform two physical performance tests (5-times chair stand test and handgrip test).
Anthropometric measurements will be assessed; body composition will be evaluated by bioelectrical impedance analysis. A venous blood draw will be executed for evaluation of irisin levels after signing a written consent form.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic obesity | – | –BMI>30, bioelectric impedance positive for sarcopenic obesity (FM% [fat mass percentage] female >43%, male >31% AND SMM/W [skeletal muscle mass/weight] female <28%, male <37%), any one of the physical performance test positive (5-times chair stand test >17 s OR handgrip strength test <35,5 kg for males, <20 kg for females). |
| Non-sarcopenic obesity | – | –BMI>30, bioelectric impedance negative for sarcopenic obesity. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from our Center's patients. A physician will screen the eligible patients from the automatic search on the database from the program Smart Digital Clinic.
Key inclusion criteria (5 listed)
- Diabetes mellitus type 2 diagnosed less than 10 years before
- age >60 years
- BMI (Body Mass Index) >30 kg/m2
- eGFR (estimated Glomerular Filtration Rate) >30 ml/min
- On stable antidiabetic therapy for at least 3 months
Key exclusion criteria (11 listed)
- Insulin or insulin secretagogues use
- Diabetes mellitus type 1, previous diabetic ketoacidosis
- Neuromuscular diseases
- Endocrinopathies that may cause myopathies (hypercortisolism, GH [growth hormone] deficiency, acromegaly, adrenal insufficiency, partial hypopituitarism or panhypopituitarism, male hypogonadism, hyperparathyroidism, hypoparathyroidism)
- Severe vit. D deficiency (<12 ng/ml)
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
Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity
Time frame: Baseline
Differences in glycated hemoglobin or in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) in patients with sarcopenic obesity vs non-sarcopenic obesity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 35196654Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23.
- Results publication: PubMed 27220658Shoukry A, Shalaby SM, El-Arabi Bdeer S, Mahmoud AA, Mousa MM, Khalifa A. Circulating serum irisin levels in obesity and type 2 diabetes mellitus. IUBMB Life. 2016 Jul;68(7):544-56. doi: 10.1002/iub.1511. Epub 2016 May 24.
- Results publication: PubMed 34190188Oguz A, Sahin M, Tuzun D, Kurutas EB, Ulgen C, Bozkus O, Gul K. Irisin is a predictor of sarcopenic obesity in type 2 diabetes mellitus: A cross-sectional study. Medicine (Baltimore). 2021 Jul 2;100(26):e26529. doi: 10.1097/MD.0000000000026529.
- 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.
Francesco Giorgino, MD, PhD principal investigator
Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari
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 Sarcopenia and Obesity, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Giorgino, MD, PhD (+390805593522, francesco.giorgino@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity (time frame: Baseline). 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 NCT05908812, which also lists 3 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 Aug 2024.