NCT03725709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

January 31, 2020

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

September 27, 2018

Last Update Submit

January 29, 2020

Conditions

Diagnoses DiseaseDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS]

    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)

    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

Study Arms (1)

All patients

spinal anesthesia

Procedure: spinal anesthesia

Interventions

spinal anesthesiaPROCEDURE

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.

All patients

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with received spinal anesthesia and had written informed consent

You may qualify if:

  • Diabetes group
  • years of age
  • Type 2 diabetes patient by clinical diagnosis
  • American Association of Anesthesiologists (ASA)≦III
  • Control group (non-diabetic group):
  • years of age
  • No history of DM and other systemic illness
  • American Association of Anesthesiologists (ASA)≦ II

You may not qualify if:

  • patient refuses to sign informed consent
  • patients with coagulopathy, systemic infective disease and severe liver and renal function impairment.
  • patients with spine or brain tumor and severe CNS disease.
  • 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.
  • Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be centrifuged for 10 min at 4 °C and 4000 rpm. The supernatant (plasma) samples will be stored in aliquots at -80 °C until analysis. CSF samples will be stored in aliquots at -80 °C before analysis. The sample will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS) in the Metabolomic Core Laboratory at Chang Gung Memorial Hospital or Chang Gung University. Demographic data including age, gender, body weight, blood pressure and past medical data will be investigated. Blood HbA1c, blood/CSF glucose and insulin level also will be measured.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 31, 2018

Study Start

August 1, 2016

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

January 31, 2020

Record last verified: 2018-09

Locations

TW(1)