From Skin Fibroblasts to Neural Stem Cells to Investigate in Vitro the Impact of Diabetes on Adult Neurogenesis

NCT ID: NCT05755321

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-05-14

Brief Summary

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Obesity and glucose intolerance or overt diabetes are increasing at an alarming rate in the population, and are bound to become a public health issue and a major cause of disability, loss of independence and high social costs in the near future. A large body of evidence has in recent years highlighted, among the negative effects of overnutrition and glucose dysmetabolism, also an acceleration of cognitive decline and of brain senescence, through cellular (vascular, neuronal, or both) and molecular mechanisms still incompletely clarified. Understanding how overweight and impaired glucose homeostasis negatively affect brain function represents both a major scientific challenge and an avenue to early detection and possibly prevention of this invalidating complication. The aim of this project is to obtain neuronal progenitor-like cells from skin fibroblasts in order to correlate patient-specific metabolism to adult neural stem cell (NSC) and neuronal function in vitro.

Detailed Description

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* Analysis of skin fibroblasts from normal, obese, lean/diabetic and obese/diabetic individuals and in vitro epigenetic conversion, as revealed by morphological changes, loss of mesenchymal markers and expression of pluripotency genes.
* To re-differentiate patient-derived pluripotent cells into neural progenitor (NP) and to test their proliferative, self-renewal and multilineage differentiation capacity.
* To evaluate neuronal cells derived from patient and control pluripotent cells for a number functional and biochemical parameters (apoptosis/autophagy, mitochondrial potential, reactive oxygen species etc.) relevant to neurodegenerative disorders.

Conditions

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Diabetes Mellitus, Type 2 Diabetes Mellitus Type 2 in Obese Diabetes Mellitus Type 2 in Nonobese Obesity Cognitive Dysfunction Metabolism Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BMI<25 and T2DM

10 Subjects with Body Mass Index (BMI) \<25 with Type 2 Diabetes Mellitus (T2DM) of both sex.

Skin biopsy

Intervention Type OTHER

Skin biopsy performed during surgery.

BMI<25 without T2DM

10 Subjects with Body Mass Index (BMI) \<25 without Type 2 Diabetes Mellitus (T2DM) of both sex.

Skin biopsy

Intervention Type OTHER

Skin biopsy performed during surgery.

BMI>30 and T2DM

10 Subjects with Body Mass Index (BMI) \>30 with Type 2 Diabetes Mellitus (T2DM) of both sex.

Skin biopsy

Intervention Type OTHER

Skin biopsy performed during surgery.

BMI>30 without T2DM

10 Subjects with Body Mass Index (BMI) \>30 without Type 2 Diabetes Mellitus (T2DM) of both sex.

Skin biopsy

Intervention Type OTHER

Skin biopsy performed during surgery.

Interventions

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Skin biopsy

Skin biopsy performed during surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes with BMI \< 25 (normal weight) and BMI \> 30 (obese) with or without T2DM with an indication for surgery

Exclusion Criteria

* Malignant neoplastic diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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geltrude mingrone

Role: PRINCIPAL_INVESTIGATOR

Policlinico A. Gemelli IRCCS

Locations

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Mingrone Geltrude

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Prot 9693/18 ID:1910

Identifier Type: -

Identifier Source: org_study_id

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