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1-hour Post-load Hyperglycemia and Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363516
Recruitment Status : Unknown
Verified December 2017 by Maria Perticone, University Magna Graecia.
Recruitment status was:  Recruiting
First Posted : December 6, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Perticone, University Magna Graecia

Brief Summary:
Insulin resistance (IR), beyond its well-defined role in the appearance and progression of diabetes mellitus (DM), is the recognized pathogenetic factor underlying vascular aging. Recently, the existence of a "cerebral" IR, responsible of the appearance and progression of many forms of dementia and mild cognitive impairment (MCI), has been hypothesized. On the other hand, it is well known that DM acts as a cardiovascular (CV) risk factor per se. In the last years it has been demonstrated that also glucose normotolerant subjects who exhibit plasma glucose levels >155 mg/dL 1h-post load, have a CV risk similar to that of diabetic patients. Thus, these category of subjects is characterized by IR and, being MCI the expression of IR in the brain, the principal hypothesis of our study is that these subjects may also develop neuropsychological alterations, earlier with respect of the general population.

Condition or disease Intervention/treatment
Glucose Metabolism Disorders Mild Cognitive Impairment Diagnostic Test: Cerebral 3 Tesla MRI

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Early Prediction of Mild Cognitive Impairment in Glucose Normotolerant Subjects With 1-hour Post-load Plasma Glucose >155 mg/dL
Actual Study Start Date : October 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
Cases
Glucose normotolerant subjects with 1-h post-load plasma glucose >155 mg/dL
Diagnostic Test: Cerebral 3 Tesla MRI
Subjects will be examined using a 3 Tesla MR750 GE MRI scanner with an eight-channel head coil. All participants will undergo the same MRI protocol, including: whole-brain 3D T1-weighted spoiled gradient recalled (SPGR) (BRAVO, voxel size of 1 × 1 × 1 mm3), DTI (voxel size 2 × 2 × 2 mm3, 27 directions with gradients at a b-value of 1,000 s/mm2 and 4 b = 0 images) and conventional 2D T2-weighted,T2 (FLAIR) and T2 gradient echo.
Other Name: Neuropsychological evaluation

Controls
Glucose normotolerant subjects with 1-h post-load plasma glucose <155 mg/dL
Diagnostic Test: Cerebral 3 Tesla MRI
Subjects will be examined using a 3 Tesla MR750 GE MRI scanner with an eight-channel head coil. All participants will undergo the same MRI protocol, including: whole-brain 3D T1-weighted spoiled gradient recalled (SPGR) (BRAVO, voxel size of 1 × 1 × 1 mm3), DTI (voxel size 2 × 2 × 2 mm3, 27 directions with gradients at a b-value of 1,000 s/mm2 and 4 b = 0 images) and conventional 2D T2-weighted,T2 (FLAIR) and T2 gradient echo.
Other Name: Neuropsychological evaluation




Primary Outcome Measures :
  1. Evidence of early neuropsychological and/or cerebral morphological/functional alterations of MCI in cases [ Time Frame: 1 month after enrollment ]
    Neuropsychological tests will be administered to all the study participants. All subjects will undergo an accurate evaluation of all the major cerebral functions in order to detect early alterations suggestive of mild cognitive impairment. Furthermore, all subjects will undergo a cerebral magnetic resonance using a 3 Tesla MR750 GE MRI scanner with an eight-channel head coil. All participants will undergo the same MRI protocol, including: whole-brain 3D T1-weighted spoiled gradient recalled (SPGR) (BRAVO, voxel size of 1 × 1 × 1 mm3), DTI (voxel size 2 × 2 × 2 mm3, 27 directions with gradients at a b-value of 1,000 s/mm2 and 4 b = 0 images) and conventional 2D T2-weighted,T2 (FLAIR) and T2 gradient echo. This test will investigate possible morphological and functional alterations suggestive of early dementia/MCI.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects of both sexes, aged >55 yrs, afferent to our Internal Medicine Ward for cardio-metabolic risk factors screening
Criteria

Inclusion Criteria:

  • Subjects of both sex aged 55 years or older
  • Ability to give informed written consent
  • Mini mental state evaluation (MMSE) >20 at visit 1

Exclusion Criteria:

  • Diabetes mellitus
  • Clinically evident dementia or cognitive impairment
  • Previous diagnosis of any disease predisposing to the risk of cognitive impairment (eg.: arterial hypertension, lipid metabolism alterations, obesity)
  • Liver cirrhosis
  • Family history of dementia and/or cognitive impairment
  • History of alcohol or drugs abuse
  • Use of medications influencing glucose homeostasis or cognitive functions
  • Contraindications to undergo cerebral 3T-MRI
  • Previous transient ischemic attack or stroke
  • History of malignancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363516


Contacts
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Contact: Maria Perticone, Dr 0039 320 8592076 mariaperticone@hotmail.com

Locations
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Italy
University Magna Graecia of Catanzaro - Department of Medical and Surgical Sciences - Internal Medicine and Geriatrics Units Recruiting
Catanzaro, Italy, 88100
Contact: Maria Perticone, Dr    0039 320 8592076    mariaperticone@hotmail.com   
Sub-Investigator: Franco Arturi, Prof         
Sponsors and Collaborators
Maria Perticone
Investigators
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Principal Investigator: Maria Perticone, Dr University Magna Graecia of Catanzaro
Publications:
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Responsible Party: Maria Perticone, Principal Investigator, University Magna Graecia
ClinicalTrials.gov Identifier: NCT03363516    
Other Study ID Numbers: UNICZ01
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders