Diabetic AngiopathiesNCT05068895
Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes
An observational study of Diabetic Angiopathies and Diabetes Mellitus, Type 2, run by Zhiming Zhu at 1 site in China.
Trial summary
The prevalence of lower extremity arterial disease (LEAD) in patients with diabetes increases significantly and are characterized with obvious arteriosclerosis that are caused by multiple metabolic disorders. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Angiopathies, Diabetes Mellitus, Type 2
- What is being tested?
- liquid chromatography-mass spectrometry
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 15 Oct 2021
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We collected serum samples and clinical data of 74 volunteers and patients with T2DM who hospitalized in our department from June 2021 to September 2021.
Who may be able to join
- age ranges from 18 to 100 years old
- Signed informed consent and agreed to participate in this study
- The diagnosis of T2DM is based on standard criteria recommended by WHO since 1999
- The diagnosis of T2DM patient with LEAD is based on standard criteria recommended by Chinese guideline on prevention and management of diabetic foot (2019 edition)(II).
Who cannot join
- younger than 18 years old or older than 100 years old
- acute infection during the preceding 3 months
- drugs or alcohol addicts
- cancer
- type 1 diabetes
- patients with mental abnormality who are uncooperative with this study
- pregnant or lactating women
- refuse to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Zhencheng Yan, MD, 86-023-68757882, zhenchengyan@sina.com
About this study
Official title: Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach
The prevalence of lower extremity arterial disease (LEAD) in patients with diabetes increases significantly and are characterized with obvious arteriosclerosis that are caused by multiple metabolic disorders. Metabolomics measures the metabolites in biological fluids or tissues that generated under certain conditions via rapidly evolving high-throughput technology. Herein, the investigators designed the study to characterize the serum metabolic profiles of LEAD patients and identify metabolic biomarkers using metabolomics. The serum of volunteers, type 2 diabetes mellitus(T2DM) patients with or without LEAD were collected and analyzed using liquid chromatography-mass spectrometry(LC-MS) coupled with a series of multivariate statistical analyses.
- Conditions
- Diabetic Angiopathies, Diabetes Mellitus, Type 2
- Being tested
- liquid chromatography-mass spectrometry
- Keywords
- Diabetes Mellitus, Type 2, Lower extremity artery disease, Metabolic Profiles, Metabolic biomarkers, Metabolomics, iquid chromatography-mass spectrometry
- Medical subject headings
- Diabetic Angiopathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid chromatography-mass spectrometryOther
Also called Metabolomics
Metabolomics is a rapidly evolving high-throughput technology that allows the measurement of the entire complement of metabolites generated by biochemical reactions under certain conditions in biological fluids or tissues. This technology has been used extensively to identify biomarkers in various cancers, nervous system diseases, cardiovascular diseases, pituitary diseases, and other diseases. The identification of biomarkers can be clinically useful for a more accurate diagnosis, prognosis, and treatment choice as well as disease monitoring. Among mass spectrometry (MS) methods, liquid chromatography-mass spectrometry (LC-MS) has been recognized as a robust metabolomics tool and has been widely applied in metabolite identification and quantification due to its high sensitivity, peak resolution, and repro- ducibility.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Volunteers with normal glucose tolerance. Receives: Other: liquid chromatography-mass spectrometry | |
| Group2 | type 2 diabetic patients without microvascular (retinopathy, nephropathy or neuropathy) or macrovascular (coronary, cerebrovascular or lower extremity arterial disease) complications. Receives: Other: liquid chromatography-mass spectrometry | |
| Group3 | type 2 diabetic patients with lower extremity artery disease diagnosed through the measurement of ABI (the ratio of ankle-to-brachial systolic blood pressure). Receives: Other: liquid chromatography-mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic profiles of lower extremity artery disease
LC-MS analysis will be performed using a Q ExactiveTM HF-X liqiud chromatograph system coupled with a Thermo ScientificTM OrbitrapTM mass spectrometer according to a previously published procedure to detect the peak, identify the metabolites and perform the PCA and OPLS-DA analyses to better visualize the subtle similarities and differences among the complex datasets.
Measured: 4 months
Secondary outcomes (2)
Potential biomarker analysis for discrimination
Screening for potential biomarkers will be performed according to the VIP value (VIP > 1.0) and significance test (P < 0.05) from the OPLS-DA model.
Measured: 4 months
Pathway analysis of differential metabolites
Conducting pathway analysis for the significant metabolites identified by using MetaboAnalyst.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jun 2021
- Primary completion9 Oct 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
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 Diabetic AngiopathiesStudies 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
- Cross-sectional
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiming Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiming Zhu, Third Military Medical University
- Investigators
- Zhencheng Yan, MD, Study director, The third hospital affiliated to the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068895
- Sponsor's protocol ID
- MP of LEAD
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
You M, Liu Y, Wang B, Li L, Zhang H, He H, Zhou Q, Cao T, Wang L, Zhao Z, Zhu Z, Gao P, Yan Z. Asprosin induces vascular endothelial-to-mesenchymal transition in diabetic lower extremity peripheral artery disease. Cardiovasc Diabetol. 2022 Feb 15;21(1):25. doi: 10.1186/s12933-022-01457-0.
PubMed 35168605
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach
- ClinicalTrials.gov ID
- NCT05068895
- Acronym / sponsor ID
- MP of LEAD
- Conditions
- Diabetic Angiopathies, Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Lower extremity artery disease, Metabolic Profiles, Metabolic biomarkers, Metabolomics, iquid chromatography-mass spectrometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Zhiming ZhuUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 9 Oct 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 6 Oct 2021 (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 prevalence of lower extremity arterial disease (LEAD) in patients with diabetes increases significantly and are characterized with obvious arteriosclerosis that are caused by multiple metabolic disorders. Metabolomics measures the metabolites in biological fluids or tissues that generated under certain conditions via rapidly evolving high-throughput technology. Herein, the investigators designed the study to characterize the serum metabolic profiles of LEAD patients and identify metabolic biomarkers using metabolomics. The serum of volunteers, type 2 diabetes mellitus(T2DM) patients with or without LEAD were collected and analyzed using liquid chromatography-mass spectrometry(LC-MS) coupled with a series of multivariate statistical analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Other: liquid chromatography-mass spectrometryVolunteers with normal glucose tolerance. |
| Group2 | – | Other: liquid chromatography-mass spectrometrytype 2 diabetic patients without microvascular (retinopathy, nephropathy or neuropathy) or macrovascular (coronary, cerebrovascular or lower extremity arterial disease) complications. |
| Group3 | – | Other: liquid chromatography-mass spectrometrytype 2 diabetic patients with lower extremity artery disease diagnosed through the measurement of ABI (the ratio of ankle-to-brachial systolic blood pressure). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We collected serum samples and clinical data of 74 volunteers and patients with T2DM who hospitalized in our department from June 2021 to September 2021.
Key inclusion criteria (4 listed)
- age ranges from 18 to 100 years old
- Signed informed consent and agreed to participate in this study
- The diagnosis of T2DM is based on standard criteria recommended by WHO since 1999
- The diagnosis of T2DM patient with LEAD is based on standard criteria recommended by Chinese guideline on prevention and management of diabetic foot (2019 edition)(II).
Key exclusion criteria (8 listed)
- younger than 18 years old or older than 100 years old
- acute infection during the preceding 3 months
- drugs or alcohol addicts
- cancer
- type 1 diabetes
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 |
|---|---|---|
| liquid chromatography-mass spectrometryAlso: MetabolomicsMetabolomics is a rapidly evolving high-throughput technology that allows the measurement of the entire complement of metabolites generated by biochemical reactions under certain conditions in biological fluids or tissues. This technology has been used extensively to identify biomarkers in various cancers, nervous system diseases, cardiovascular diseases, pituitary diseases, and other diseases. The identification of biomarkers can be clinically useful for a more accurate diagnosis, prognosis, and treatment choice as well as disease monitoring. Among mass spectrometry (MS) methods, liquid chromatography-mass spectrometry (LC-MS) has been recognized as a robust metabolomics tool and has been widely applied in metabolite identification and quantification due to its high sensitivity, peak resolution, and repro- ducibility. | Other | Group1, Group2, Group3 |
Primary outcome
Metabolic profiles of lower extremity artery disease
Time frame: 4 months
LC-MS analysis will be performed using a Q ExactiveTM HF-X liqiud chromatograph system coupled with a Thermo ScientificTM OrbitrapTM mass spectrometer according to a previously published procedure to detect the peak, identify the metabolites and perform the PCA and OPLS-DA analyses to better visualize the subtle similarities and differences among the complex datasets.
2 secondary outcomes
Potential biomarker analysis for discrimination
Time frame: 4 months
Pathway analysis of differential metabolites
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 35168605You M, Liu Y, Wang B, Li L, Zhang H, He H, Zhou Q, Cao T, Wang L, Zhao Z, Zhu Z, Gao P, Yan Z. Asprosin induces vascular endothelial-to-mesenchymal transition in diabetic lower extremity peripheral artery disease. Cardiovasc Diabetol. 2022 Feb 15;21(1):25. doi: 10.1186/s12933-022-01457-0.
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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 third hospital affiliated to the Third Military Medical University
Chongqing, China
Zhencheng Yan, MD study director
The third hospital affiliated to the Third Military Medical University
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 Diabetic Angiopathies and Diabetes Mellitus, Type 2, run by Zhiming Zhu at 1 site in China.
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 4 inclusion and 8 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 6 Oct 2021. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic profiles of lower extremity artery disease (time frame: 4 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 NCT05068895, 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 6 Oct 2021.