Diabetic CardiomyopathiesNCT04534894
Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With FLIM
An observational study of Diabetic Cardiomyopathies, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
Diabetic Cardiomyopathy (DCM) is disease of myocardial structure and function which is independent of hypertension, coronary heart disease, heart valve abnormalities, and other types of heart disease. DCM affects approximately 12% of diabetics and also appeared in some patients with well-controlled blood glucose. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Cardiomyopathies
- What is being tested?
- fluorescence lifetime imaging microscopy
- How many people
- 243 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetes patients, divided into two groups, based on the diastolic funciton
Who may be able to join
- Male or female, aged 18-80 years old;
- Echocardiography showed that the cardiac structure was normal and the left ventricular ejection fraction was more than 50%;
- patients with type 2 diabetes mellitus;
- Body mass index (BMI) was 20-25 kg / m2 in male and 19-24 kg / m2 in female;
- No other drugs except hypoglycemic drugs were taken in one month;
- Sign informed consent form before entering this study.
Who cannot join
- Patients with type 1 diabetes mellitus;
- Patients with diabetic ketoacidosis in the past;
- Patients with coronary heart disease or with myocardial ischemia indicated by ECG;
- EGFR < 60ml / min / 1.73m2 in recent one month;
- Chronic liver disease, or the levels of alanine aminotransferase and glutamic oxaloacetic transaminase were more than 3 times of the upper limit of the normal before enrollment;
- Abnormal thyroid function;
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- Abnormal tumor index;
- Dyslipidemia;
- Pregnant and lactating women;
- Allergy to contrast media.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With Fluorescence Lifetime Imaging Microscopy (FLIM)
Diabetic Cardiomyopathy (DCM) is disease of myocardial structure and function which is independent of hypertension, coronary heart disease, heart valve abnormalities, and other types of heart disease. DCM affects approximately 12% of diabetics and also appeared in some patients with well-controlled blood glucose. There is no specific and effective diagnostic method of DCM currently. Since it is well known that the dysfunction of myocardial metabolism caused by hyperglycemia and insulin resistance induces DCM, the method of evaluation of the metabolism will assist the diagnosis of DCM.
Nicotinamide adenine dinucleotide (phosphate) (NAD(P)H) is one of important coenzymes involved in biological metabolism. Fluorescence lifetime microscopy (FLIM) can detect the metabolic status based on the fluorescence characteristics of NAD(P)H. Previous studies have reported that NAD(P)H fluorescence lifetime can be used to assess the metabolic status of living cardiomyocytes cultured in vitro, and metabolism changes related to myocardial infarction and heart failure in rats. the investigators detected the metabolic status by label-free FLIM on the myocardial tissues and blood plasma in a rat model of type 2 diabetic cardiomyopathy, and found FLIM could provide valuable information about the myocardial metabolism by detecting the NAD(P)H fluorescence lifetime of blood plasma.
Read more
Recently, The investigators have explored the method of the FLIM in clinical study. The investigators used FLIM to compare the NAD(P)H fluorescence lifetime of blood plasma in healthy participants, type 2 diabetic patients with normal diastolic function and with diastolic dysfunction. The results showed that the NAD(P)H fluorescence life parameter of a2 was lower in type 2 diabetic patients with diastolic dysfunction (30.5±2.7%) than in healthy participants (41.5±4.8%) and type 2 diabetic patients with normal diastolic function (37.8±3.7%). Therefore, The investigators propose FLIM can provide valuable information about the myocardial metabolism, and it can be used as a non-invasive, label-free, and rapid screening method of diagnosis of DCM.
In this study, the investigators will recruit 243 patients with type 2 diabetes and divide them into two groups: normal diastolic function group (DM Group) and diastolic dysfunction group (DCM Group), based on the symptoms, laboratory examination and echocardiographic results. Then FLIM will be applied to detect the NAD(P)H fluorescence characteristics of venous blood of all patients. After that, the correlation between the parameters of diastolic function (E peak, E/E' ratio, left atrial volume, NT-proBNP) and the parameters of metabolism status (NAD(P)H fluorescence life parameter of a2 and the ratio of bound state/free state NAD(P)H) will be analyzed. This study will verify FLIM is helpful to diagnose DCM.
- Conditions
- Diabetic Cardiomyopathies
- Being tested
- fluorescence lifetime imaging microscopy
- Keywords
- diabetic cardiomyopathy, fluorescence lifetime imaging microscopy, metabolism
- Medical subject headings
- Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence lifetime imaging microscopyDiagnostic test
collect 2mL of venous blood and use fluorescence lifetime imaging microscopy to exam NADH fluorescence characteristics of it
| Study group | Role | What they receive |
|---|---|---|
| DM group and DCM group | DM group: type 2 diabetes with normal diastolic function DCM group: type 2 diabetes with diastolic dysfunction Receives: Diagnostic Test: fluorescence lifetime imaging microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy
(NAD(P)H fluorescence life parameter of a2 (%) in venous blood is lower in DCM patients than DM patients.
Measured: 12 month
fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy
the ratio of bound state/free state NAD(P)H) (%) is lower in DCM patients than DM patients.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- guangyu chen, doctor, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534894
- Sponsor's protocol ID
- XH-20-015
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rubler S, Dlugash J, Yuceoglu YZ, Kumral T, Branwood AW, Grishman A. New type of cardiomyopathy associated with diabetic glomerulosclerosis. Am J Cardiol. 1972 Nov 8;30(6):595-602. doi: 10.1016/0002-9149(72)90595-4. No abstract available.
PubMed 4263660Singh RM, Waqar T, Howarth FC, Adeghate E, Bidasee K, Singh J. Hyperglycemia-induced cardiac contractile dysfunction in the diabetic heart. Heart Fail Rev. 2018 Jan;23(1):37-54. doi: 10.1007/s10741-017-9663-y.
PubMed 29192360De Jong KA, Lopaschuk GD. Complex Energy Metabolic Changes in Heart Failure With Preserved Ejection Fraction and Heart Failure With Reduced Ejection Fraction. Can J Cardiol. 2017 Jul;33(7):860-871. doi: 10.1016/j.cjca.2017.03.009. Epub 2017 Mar 19.
PubMed 28579160Cook GA, Lavrentyev EN, Pham K, Park EA. Streptozotocin diabetes increases mRNA expression of ketogenic enzymes in the rat heart. Biochim Biophys Acta Gen Subj. 2017 Feb;1861(2):307-312. doi: 10.1016/j.bbagen.2016.11.012. Epub 2016 Nov 11.
PubMed 27845231Suhling K, Siegel J, Lanigan PM, Leveque-Fort S, Webb SE, Phillips D, Davis DM, French PM. Time-resolved fluorescence anisotropy imaging applied to live cells. Opt Lett. 2004 Mar 15;29(6):584-6. doi: 10.1364/ol.29.000584.
PubMed 15035478Wang M, Tang F, Pan X, Yao L, Wang X, Jing Y, Ma J, Wang G, Mi L. Rapid diagnosis and intraoperative margin assessment of human lung cancer with fluorescence lifetime imaging microscopy. BBA Clin. 2017 Apr 27;8:7-13. doi: 10.1016/j.bbacli.2017.04.002. eCollection 2017 Dec.
PubMed 28567338Luo T, Lu Y, Liu S, Lin D, Qu J. Phasor-FLIM as a Screening Tool for the Differential Diagnosis of Actinic Keratosis, Bowen's Disease, and Basal Cell Carcinoma. Anal Chem. 2017 Aug 1;89(15):8104-8111. doi: 10.1021/acs.analchem.7b01681. Epub 2017 Jul 18.
PubMed 28661125Jing Y, Wang Y, Wang X, Song C, Ma J, Xie Y, Fei Y, Zhang Q, Mi L. Label-free imaging and spectroscopy for early detection of cervical cancer. J Biophotonics. 2018 May;11(5):e201700245. doi: 10.1002/jbio.201700245. Epub 2018 Jan 30.
PubMed 29205885Farwell DG, Meier JD, Park J, Sun Y, Coffman H, Poirier B, Phipps J, Tinling S, Enepekides DJ, Marcu L. Time-resolved fluorescence spectroscopy as a diagnostic technique of oral carcinoma: Validation in the hamster buccal pouch model. Arch Otolaryngol Head Neck Surg. 2010 Feb;136(2):126-33. doi: 10.1001/archoto.2009.216.
PubMed 20157056Lagarto J, Dyer BT, Talbot C, Sikkel MB, Peters NS, French PM, Lyon AR, Dunsby C. Application of time-resolved autofluorescence to label-free in vivo optical mapping of changes in tissue matrix and metabolism associated with myocardial infarction and heart failure. Biomed Opt Express. 2015 Jan 7;6(2):324-46. doi: 10.1364/BOE.6.000324. eCollection 2015 Feb 1.
PubMed 25780727
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With Fluorescence Lifetime Imaging Microscopy (FLIM)
- ClinicalTrials.gov ID
- NCT04534894
- Acronym / sponsor ID
- XH-20-015
- Conditions
- Diabetic Cardiomyopathies
- Keywords
- diabetic cardiomyopathy, fluorescence lifetime imaging microscopy, metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Sep 2020 (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.
Diabetic Cardiomyopathy (DCM) is disease of myocardial structure and function which is independent of hypertension, coronary heart disease, heart valve abnormalities, and other types of heart disease. DCM affects approximately 12% of diabetics and also appeared in some patients with well-controlled blood glucose. There is no specific and effective diagnostic method of DCM currently. Since it is well known that the dysfunction of myocardial metabolism caused by hyperglycemia and insulin resistance induces DCM, the method of evaluation of the metabolism will assist the diagnosis of DCM.
Nicotinamide adenine dinucleotide (phosphate) (NAD(P)H) is one of important coenzymes involved in biological metabolism. Fluorescence lifetime microscopy (FLIM) can detect the metabolic status based on the fluorescence characteristics of NAD(P)H. Previous studies have reported that NAD(P)H fluorescence lifetime can be used to assess the metabolic status of living cardiomyocytes cultured in vitro, and metabolism changes related to myocardial infarction and heart failure in rats. the investigators detected the metabolic status by label-free FLIM on the myocardial tissues and blood plasma in a rat model of type 2 diabetic cardiomyopathy, and found FLIM could provide valuable information about the myocardial metabolism by detecting the NAD(P)H fluorescence lifetime of blood plasma.
Recently, The investigators have explored the method of the FLIM in clinical study. The investigators used FLIM to compare the NAD(P)H fluorescence lifetime of blood plasma in healthy participants, type 2 diabetic patients with normal diastolic function and with diastolic dysfunction. The results showed that the NAD(P)H fluorescence life parameter of a2 was lower in type 2 diabetic patients with diastolic dysfunction (30.5±2.7%) than in healthy participants (41.5±4.8%) and type 2 diabetic patients with normal diastolic function (37.8±3.7%). Therefore, The investigators propose FLIM can provide valuable information about the myocardial metabolism, and it can be used as a non-invasive, label-free, and rapid screening method of diagnosis of DCM.
In this study, the investigators will recruit 243 patients with type 2 diabetes and divide them into two groups: normal diastolic function group (DM Group) and diastolic dysfunction group (DCM Group), based on the symptoms, laboratory examination and echocardiographic results. Then FLIM will be applied to detect the NAD(P)H fluorescence characteristics of venous blood of all patients. After that, the correlation between the parameters of diastolic function (E peak, E/E' ratio, left atrial volume, NT-proBNP) and the parameters of metabolism status (NAD(P)H fluorescence life parameter of a2 and the ratio of bound state/free state NAD(P)H) will be analyzed. This study will verify FLIM is helpful to diagnose DCM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DM group and DCM group | – | Diagnostic Test: fluorescence lifetime imaging microscopyDM group: type 2 diabetes with normal diastolic function DCM group: type 2 diabetes with diastolic dysfunction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetes patients, divided into two groups, based on the diastolic funciton
Key inclusion criteria (6 listed)
- Male or female, aged 18-80 years old;
- Echocardiography showed that the cardiac structure was normal and the left ventricular ejection fraction was more than 50%;
- patients with type 2 diabetes mellitus;
- Body mass index (BMI) was 20-25 kg / m2 in male and 19-24 kg / m2 in female;
- No other drugs except hypoglycemic drugs were taken in one month;
Key exclusion criteria (10 listed)
- Patients with type 1 diabetes mellitus;
- Patients with diabetic ketoacidosis in the past;
- Patients with coronary heart disease or with myocardial ischemia indicated by ECG;
- EGFR < 60ml / min / 1.73m2 in recent one month;
- Chronic liver disease, or the levels of alanine aminotransferase and glutamic oxaloacetic transaminase were more than 3 times of the upper limit of the normal before enrollment;
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 |
|---|---|---|
| fluorescence lifetime imaging microscopycollect 2mL of venous blood and use fluorescence lifetime imaging microscopy to exam NADH fluorescence characteristics of it | Diagnostic test | DM group and DCM group |
Primary outcome
fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy
Time frame: 12 month
(NAD(P)H fluorescence life parameter of a2 (%) in venous blood is lower in DCM patients than DM patients.
fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy
Time frame: 12 month
the ratio of bound state/free state NAD(P)H) (%) is lower in DCM patients than DM patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Results publication: PubMed 4263660Rubler S, Dlugash J, Yuceoglu YZ, Kumral T, Branwood AW, Grishman A. New type of cardiomyopathy associated with diabetic glomerulosclerosis. Am J Cardiol. 1972 Nov 8;30(6):595-602. doi: 10.1016/0002-9149(72)90595-4. No abstract available.
- Results publication: PubMed 29192360Singh RM, Waqar T, Howarth FC, Adeghate E, Bidasee K, Singh J. Hyperglycemia-induced cardiac contractile dysfunction in the diabetic heart. Heart Fail Rev. 2018 Jan;23(1):37-54. doi: 10.1007/s10741-017-9663-y.
- Results publication: PubMed 28579160De Jong KA, Lopaschuk GD. Complex Energy Metabolic Changes in Heart Failure With Preserved Ejection Fraction and Heart Failure With Reduced Ejection Fraction. Can J Cardiol. 2017 Jul;33(7):860-871. doi: 10.1016/j.cjca.2017.03.009. Epub 2017 Mar 19.
- Results publication: PubMed 27845231Cook GA, Lavrentyev EN, Pham K, Park EA. Streptozotocin diabetes increases mRNA expression of ketogenic enzymes in the rat heart. Biochim Biophys Acta Gen Subj. 2017 Feb;1861(2):307-312. doi: 10.1016/j.bbagen.2016.11.012. Epub 2016 Nov 11.
- Results publication: PubMed 15035478Suhling K, Siegel J, Lanigan PM, Leveque-Fort S, Webb SE, Phillips D, Davis DM, French PM. Time-resolved fluorescence anisotropy imaging applied to live cells. Opt Lett. 2004 Mar 15;29(6):584-6. doi: 10.1364/ol.29.000584.
- Results publication: PubMed 28567338Wang M, Tang F, Pan X, Yao L, Wang X, Jing Y, Ma J, Wang G, Mi L. Rapid diagnosis and intraoperative margin assessment of human lung cancer with fluorescence lifetime imaging microscopy. BBA Clin. 2017 Apr 27;8:7-13. doi: 10.1016/j.bbacli.2017.04.002. eCollection 2017 Dec.
- Results publication: PubMed 28661125Luo T, Lu Y, Liu S, Lin D, Qu J. Phasor-FLIM as a Screening Tool for the Differential Diagnosis of Actinic Keratosis, Bowen's Disease, and Basal Cell Carcinoma. Anal Chem. 2017 Aug 1;89(15):8104-8111. doi: 10.1021/acs.analchem.7b01681. Epub 2017 Jul 18.
- Results publication: PubMed 29205885Jing Y, Wang Y, Wang X, Song C, Ma J, Xie Y, Fei Y, Zhang Q, Mi L. Label-free imaging and spectroscopy for early detection of cervical cancer. J Biophotonics. 2018 May;11(5):e201700245. doi: 10.1002/jbio.201700245. Epub 2018 Jan 30.
- Results publication: PubMed 20157056Farwell DG, Meier JD, Park J, Sun Y, Coffman H, Poirier B, Phipps J, Tinling S, Enepekides DJ, Marcu L. Time-resolved fluorescence spectroscopy as a diagnostic technique of oral carcinoma: Validation in the hamster buccal pouch model. Arch Otolaryngol Head Neck Surg. 2010 Feb;136(2):126-33. doi: 10.1001/archoto.2009.216.
- Results publication: PubMed 25780727Lagarto J, Dyer BT, Talbot C, Sikkel MB, Peters NS, French PM, Lyon AR, Dunsby C. Application of time-resolved autofluorescence to label-free in vivo optical mapping of changes in tissue matrix and metabolism associated with myocardial infarction and heart failure. Biomed Opt Express. 2015 Jan 7;6(2):324-46. doi: 10.1364/BOE.6.000324. eCollection 2015 Feb 1.
- 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.
guangyu chen, doctor study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Cardiomyopathies, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 kai guo, doctor (+86-21-25076143, guokai@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy (time frame: 12 month). The study lists 2 primary outcomes in all. 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 NCT04534894, which also lists 10 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 Sep 2020.