Correlation Between Melatonin Levels in Different Biological Fluids
Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05784090
Collaborator
(none)
36
1
62.3
0.6
Study Details
Study Description
Brief Summary
The goal of this observational study is to evaluate and to correlate melatonin levels in plasma, saliva and cerebrospinal fluid (CSF) samples of patients undergoing lumbar puncture diagnostic for specific neurological diseases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
36 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Livelli di Melatonina e Dei Suoi Precursori/Metaboliti in Differenti Fluidi Biologici: vi รจ Correlazione?
Actual Study Start Date
:
Oct 23, 2018
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Dec 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AD Alzheimer's Disease |
Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases
Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace.
Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.
|
| NON AD Non Alzheimer's Disease |
Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases
Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace.
Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.
|
| CT Controls |
Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases
Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace.
Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.
|
Outcome Measures
Primary Outcome Measures
- Melatonin levels in saliva [Baseline]
Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml
- Melatonin levels in plasma [Baseline]
Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml
- Melatonin levels in cerebrospinal fluid [Baseline]
Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml
Secondary Outcome Measures
- Orexin levels in cerebrospinal fluid [Baseline]
Analysis of orexin levels by ELISA kit. Values expressed in ng/ml
- Neurofilaments light chain levels (NFL) in cerebrospinal fluid [Baseline]
Analysis of NFL levels by SIMOA kit. Values expressed in pg/ml
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Neurodegenerative disease
Exclusion Criteria:
-
Age < 18 years
-
Pregnancy
-
Coagulations disorders
-
Anticoagulant therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Auxologico Italiano - S. Giuseppe Hospital | Verbania | VB | Italy |
Sponsors and Collaborators
- Istituto Auxologico Italiano
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05784090
Other Study ID Numbers:
- 21C821
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: