Metabolomic Profiling of in Patients With type2 Diabetes

January 29, 2020 updated by: Chang Gung Memorial Hospital

Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes

To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Human cerebral spinal fluid (CSF) is known to be a rich source of small molecule biomarkers for central neurological and neurodegenerative diseases. However, the metaboloic bases of CSF in diabetes patient have not been studied. In this plan, the investigators will use analytical platforms, including nuclear magnetic resonance (NMR), liquid chromatography-mass spectrometry (LC-MS), to perform quantitative metabolomics on human CSF and blood samples and further establish the human CSF Metabolome Database of DM. This work will can supply important CSF metabolic profit information and help to facilitate a wide range of metabolomic studies on central nervous system diseases and their associations disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with received spinal anesthesia and had written informed consent

Description

Inclusion Criteria:

Diabetes group

  1. .20-75 years of age
  2. .Type 2 diabetes patient by clinical diagnosis
  3. .American Association of Anesthesiologists (ASA)≦III

Control group (non-diabetic group):

  1. .20-75 years of age
  2. .No history of DM and other systemic illness
  3. .American Association of Anesthesiologists (ASA)≦ II

Exclusion Criteria:

  1. patient refuses to sign informed consent
  2. patients with coagulopathy, systemic infective disease and severe liver and renal function impairment.
  3. patients with spine or brain tumor and severe CNS disease.
  4. the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study other than DM which could compromise participation in the study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc.

  5. Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All patients
spinal anesthesia
Procedure: spinal anesthesia
Plan to enroll 120 Type 2 diabetes and 120 non-diabetes patients with received spinal anesthesia.Blood will be collected at time point of pre-anesthesia 10 minutes and CSF samples will be collected at time point during spinal anesthesia induction. Blood will be collected, drawn into EDTA-coated tube.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS]
Time Frame: Through study completion, an average of 1 year
Use metabolomic analysis to connect CSF and blood metabolomic profiles information for further clarification of the influence of DM in CNS and expect to find new reliable biomarkers in diabetes patient for early predict DM progression and outcome.
Through study completion, an average of 1 year
Exam metabolic profiles of CSF and plasma in diabetes. (Metabolites analysis of CSF and plasma)
Time Frame: Through study completion, an average of 1 year
Metabolites analysis of CSF and plasma will be investigated by NMR, LC-MS. Peak lists of all NMR and LC/MS/MS spectra will be searched against the database through a web server for metabolomic data analysis and further establish the CSF Metabolome Database.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 140-9207A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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