An observational study in Glucose Metabolism Disorders and Mild Cognitive Impairment, sponsored by Maria Perticone. Status unknown at 1 site in Italy. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2017-12-07.
Sponsored by Maria Perticone · Observational
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Among 20 studies in Glucose Metabolism Disorders with a site in Italy — 2 open to participants now, 2 under way, 1 of them phase 3. Glucose Metabolism Disorders · Italy.
Among the 20 studies in Glucose Metabolism Disorders with a site in Italy, this one is one of 2 that started in 2016, is one of 3 observational ones, and was the 6th registered.
361 studies on the registry are indexed under Glucose Metabolism Disorders; 38 are open to participants now.
Browse Glucose Metabolism Disorders studies →2 of the 20 studies in Glucose Metabolism Disorders with a site in Italy are open now. Recruiting first, the newest first:
Pfizer · Sites in Italy, United States, Brazil and 8 more countries
Ages 18+
Ultragenyx Pharmaceutical Inc · Sites in Italy, United States, Brazil and 6 more countries
Ages 2+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 29 Glucose Metabolism Disorders studies recruiting now, 9 (31%) set no upper age limit and 18 (62%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 55 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 87 across 47 observational studies indexed under Glucose Metabolism Disorders.
Median enrollment 55 across the 17 interventional studies, 140 across the 3 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
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9 of 20 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Maria Perticone as lead sponsor.
Maria Perticone has 1 study filed under Glucose Metabolism Disorders — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Glucose Metabolism Disorders with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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, in the continuum from endothelial dysfunction to atherosclerotic vascular lesions. Two different types of IR have been described: 1) a "central" IR, particularly expressed in the liver, affecting all the metabolic pathways operating at this site, and 2) a "peripheral" IR, particularly expressed in the muscle. 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, for decades DM was considered only as a hyperglycemic status, disregarding its important negative impact on vascular function and its role as a cardiovascular (CV) risk factor per se. For these reasons, in the past, DM management only consisted in reducing plasma glucose levels. In the last years our group 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.
Hypothesis and Significance The hypothesis of this study is based on the concept that glucose normotolerant subjects with 1h-post load glycemia >155 mg/dL exhibit an insulin-resistant status characterized by enhanced insulin production but reduced tissues sensitivity to the hormone action. This reduced insulin sensitivity is present many years before the appearance of the clinical conditions such as DM, arterial hypertension, dyslipidemia, etc. Insulin, insulin receptor, and its substrates are expressed in the whole central nervous system; in this site, insulin regulates food intake and body weight, and it is also involved in neurotransmitters release and synaptic plasticity. It is thus plausible that insulin may have an important role in many cognitive processes. Evidences indicate that the cognitive impairment commonly seen in many diabetic patients could be mediated by an altered signaling insulin-like growth factor-1 (IGF1)-insulin. In fact, a stream of human and experimental studies has provided convincing evidence that many forms of dementia, such as Alzheimer's disease, are metabolic diseases characterized by the brain loss of its capacity to efficiently utilize glucose for energy production and respond to critical trophic factor signals due to insulin as well as insulin-like growth factor (IGF) resistance. Thus, 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. This hypothesis may have an important clinical significance and a great social impact, since a great amount of health costs are due chronic diseases, included all forms of dementia. Furthermore, the results of this study will add important information about the understanding of the complex network of pathways operating in the appearance and progression of many of the chronic diseases, such as diabetes mellitus and dementia.
Aim of the study To investigate the presence of early neuropsychological and/or cerebral morphological alterations in two groups of subjects (Group 1: glucose normotolerant subjects with 1h-post load glycemia >155 mg/dL; Group 2: healthy subjects with 1h post-load glycemia \< 155 mg/dL).
Experimental Design
Visit 1: evaluation of inclusion/exclusion criteria, MMSE, clinical visit, all laboratory determinations, OGTT
Visit 2: neuropsychological assessment (refers to the measurement of cognitive functions and processes with the aim to establish whether a cognitive impairment is present in individuals. It is preferably performed by clinical neuropsychologists who have expertise in the study of the neural correlates of behavior and cognition. The cognitive processes to be investigated in the present study include functions such as memory, language, praxia, attention, executive functions and intelligence. The following tests will be used: MMSE, RAVLT, FCSRT, COWAT, FAB, TMT and Stroop Test, Weigl Test, BDI II, HAMA
3Tesla (T) brain magnetic resonance imaging (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.
Methodologies and statistical analyses The investigators planned to conduct an observational perspective longitudinal study. The planned number of patients is 15 for each group. In particular, will be enrolled 15 glucose normotolerant subjects with 1h post-load glycemia >155 mg/dL (Group 1), and 15 healthy subjects with 1h post-load glycemia \<155 mg/dL (Group 2).
All subjects will undergo the following study procedures:
Data will be collected in a case report form (CRF) mantained at the University Magna Graecia of Catanzaro. Data collected will be analyzed through descriptive statistic methodologies, t-test, ANOVA, linear and multiple regression, when appropriate.
Expected outcomes On the basis of previously published literature and of pathophysiologic hypothesis, the expected outcomes of this project are the early recognition of neuropsychological and/or neuroimaging alterations suggestive of mild cognitive impairment in insulin-resistant subjects without clinical evidence of metabolic diseases typical of the insulin-resistant status (diabetes mellitus, arterial hypertension, metabolic syndrome, etc.).
Significance and Innovation The results of this study could represent an important milestone in the comprehension of the complex pathophysiological mechanisms underlying the appearance of cognitive disorders in subjects with apparently different risk factors. If this hypothesis -that IR is the trait d'union between metabolic and cerebral alterations- will be confirmed, a new important link (i.e.: the relationship between IR/glucose metabolism and cerebral functions) could be further explored in future studies in order to plan preventive/therapeutic strategies for subjects with any type of insulin resistance, before the appearance of the clinical manifestations of IR in any of the target organs. The major innovation of this study is represented by the fact that IR could be considered not only as a cardiometabolic risk factor, but also as a cerebral one.
Translational relevance This study has an important scientific relevance since it is, to the investigators' knowledge, the first one merging both neuropsychological and metabolic aspects in a pre-clinical status. Thus, if the hypothesis of the study will be confirmed, the management of patients with IR could also include neuropsychological and neuroimaging assessments in order to early detect cognitive impairment.
Subjects of both sexes, aged >55 yrs, afferent to our Internal Medicine Ward for cardio-metabolic risk factors screening
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glucose normotolerant subjects with 1-h post-load plasma glucose \>155 mg/dL
Diagnostic Test: Cerebral 3 Tesla MRI
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.
Also known as: Neuropsychological evaluation
Evidence of early neuropsychological and/or cerebral morphological/functional alterations of MCI in cases
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.
Time frame: 1 month after enrollment
Plan to share: Undecided
Started Oct 2016 (actual). Primary completion is estimated for Sep 2018, 23 months after the start.
Of 23 observational studies under Glucose Metabolism Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 67. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Glucose Metabolism Disorders →