Correlation Between Melatonin Levels in Different Biological Fluids

March 13, 2023 updated by: Istituto Auxologico Italiano

Livelli di Melatonina e Dei Suoi Precursori/Metaboliti in Differenti Fluidi Biologici: vi è Correlazione?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • VB
      • Verbania, VB, Italy
        • Recruiting
        • Istituto Auxologico Italiano - S. Giuseppe Hospital
        • Contact:

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

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neurodegenerative disorders

Description

Inclusion Criteria:

  • Neurodegenerative disease

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Coagulations disorders
  • Anticoagulant therapy

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melatonin levels in saliva
Time Frame: Baseline
Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml
Baseline
Melatonin levels in plasma
Time Frame: Baseline
Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml
Baseline
Melatonin levels in cerebrospinal fluid
Time Frame: Baseline
Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orexin levels in cerebrospinal fluid
Time Frame: Baseline
Analysis of orexin levels by ELISA kit. Values expressed in ng/ml
Baseline
Neurofilaments light chain levels (NFL) in cerebrospinal fluid
Time Frame: Baseline
Analysis of NFL levels by SIMOA kit. Values expressed in pg/ml
Baseline

Collaborators and Investigators

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

Sponsor

Istituto Auxologico Italiano

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)

October 23, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21C821

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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