Diabetes Mellitus, Type 2NCT05988346
Ghrelin and Diastolic Heart Function
An observational study of Diabetes Mellitus, Type 2 and Obesity, Abdominal, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Abdominal, Diastolic Dysfunction
- What is being tested?
- abdominal plastic intervention
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2016to 1 Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The authors will enroll T2DM obese patients, according to the evidence or not of LV diastolic dysfunction, and then divided in three groups. The LV diastolic dysfunction was characterized as indicated by international recommendations, by the values of E/E' ratio (18). Thus, the patients without LV diastolic dysfunction (E/E'<9) were characterized as group 1. Those with LV diastolic dysfunction (E/E'>9), were divided in two groups, in accordance with the E/E' values: group 2 (the patients with 9<E/E'<13), and group 3 (the patients with E/E'>13). Obesity will be diagnosed as body mass index (BMI) > 30 (15). All enrolled patients will have T2DM according to international guidelines diagnostic criteria: evidence of fasting plasma glucose of ≥7.0 mmol/L (126 mg/dL; impaired fasting glucose [IFG]), a 2-hour glucose of ≥11.1 mmol/L during a 75 g oral glucose tolerance test (GTT) (>200 mg/dL; impaired glucose tolerance [IGT]), or a plasma hemoglobin (Hb) A1c of ≥48 mmol/mol (≥6.5%), (16).
Who may be able to join
- Clinical diagnosis of T2DM obese patients;
- T2DM obese patients under anti-diabetic full medical therapy and glycemic control.
Who cannot join
- clinical diagnosis of type 1 diabetes;
- T2DM patients in poor glycemic control (HbA1c values of >7%);
- chronic neurological disorders;
- heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF <55%);
- severe anemia;
- thyroid dysfunction;
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- kidney failure;
- uncontrolled blood pressure (blood pressure > 140/90 mmHg on two occasions 2 weeks apart);
- inflammatory chronic disease;
- neoplastic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes
In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.
- Being tested
- abdominal plastic intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal plastic interventionProcedure or surgery
According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction. | Not described Receives: Procedure: abdominal plastic intervention | |
| T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction. | Not described Receives: Procedure: abdominal plastic intervention | |
| T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction. | Not described Receives: Procedure: abdominal plastic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
normalization of LV diastolic dysfunction
At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2016
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celestino Sardu, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988346
- Sponsor's protocol ID
- 0408052023
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sardu C, D'Onofrio N, Trotta MC, Balestrieri ML, Nicoletti GF, D'Amico G, Fumagalli C, Contaldi C, Pacileo G, Scisciola L, Nicoletti M, Marfella LV, Sbriscia M, Sasso FC, Signoriello G, Paolisso G, Marfella R. Could Ghrelin Expression Regulate Diastolic Cardiac Function in Type 2 Diabetic Obese Patients? Diabetes Metab Res Rev. 2025 May;41(4):e70049. doi: 10.1002/dmrr.70049.
PubMed 40323144
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes
- ClinicalTrials.gov ID
- NCT05988346
- Acronym / sponsor ID
- 0408052023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 Aug 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.
In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction. | – | Procedure: abdominal plastic intervention |
| T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction. | – | Procedure: abdominal plastic intervention |
| T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction. | – | Procedure: abdominal plastic intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The authors will enroll T2DM obese patients, according to the evidence or not of LV diastolic dysfunction, and then divided in three groups. The LV diastolic dysfunction was characterized as indicated by international recommendations, by the values of E/E' ratio (18). Thus, the patients without LV diastolic dysfunction (E/E'<9) were characterized as group 1. Those with LV diastolic dysfunction (E/E'>9), were divided in two groups, in accordance with the E/E' values: group 2 (the patients with 9<E/E'<13), and group 3 (the patients with E/E'>13). Obesity will be diagnosed as body mass index (BMI) > 30 (15). All enrolled patients will have T2DM according to international guidelines diagnostic criteria: evidence of fasting plasma glucose of ≥7.0 mmol/L (126 mg/dL; impaired fasting glucose [IFG]), a 2-hour glucose of ≥11.1 mmol/L during a 75 g oral glucose tolerance test (GTT) (>200 mg/dL; impaired glucose tolerance [IGT]), or a plasma hemoglobin (Hb) A1c of ≥48 mmol/mol (≥6.5%), (16).
Key inclusion criteria (2 listed)
- Clinical diagnosis of T2DM obese patients;
- T2DM obese patients under anti-diabetic full medical therapy and glycemic control.
Key exclusion criteria (10 listed)
- clinical diagnosis of type 1 diabetes;
- T2DM patients in poor glycemic control (HbA1c values of >7%);
- chronic neurological disorders;
- heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF <55%);
- severe anemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal plastic interventionAccording to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study. | Procedure or surgery | T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction., T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction., type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction. |
Primary outcome
normalization of LV diastolic dysfunction
Time frame: 12 months
At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function.
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 24 Aug 2023.
- Derived from this study: PubMed 40323144Sardu C, D'Onofrio N, Trotta MC, Balestrieri ML, Nicoletti GF, D'Amico G, Fumagalli C, Contaldi C, Pacileo G, Scisciola L, Nicoletti M, Marfella LV, Sbriscia M, Sasso FC, Signoriello G, Paolisso G, Marfella R. Could Ghrelin Expression Regulate Diastolic Cardiac Function in Type 2 Diabetic Obese Patients? Diabetes Metab Res Rev. 2025 May;41(4):e70049. doi: 10.1002/dmrr.70049.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, Type 2 and Obesity, Abdominal, run by University of Campania Luigi Vanvitelli 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 2 inclusion and 10 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 24 Aug 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?
normalization of LV diastolic dysfunction (time frame: 12 months). 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 NCT05988346, which also lists 1 linked publication.
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 24 Aug 2023.