NCT05755321

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2023

Completed
Last Updated

March 10, 2023

Status Verified

February 1, 2023

Enrollment Period

3.3 years

First QC Date

February 23, 2023

Last Update Submit

March 8, 2023

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus Type 2 in ObeseDiabetes Mellitus Type 2 in NonobeseObesityCognitive DysfunctionMetabolism Disorder

Outcome Measures

Primary Outcomes (3)

  • Fibroblasts culture characterization

    To determine whether cells from dysmetabolic individuals are defective (in term of proliferation, senescence, cell death) when compared with control-derived cells

    About one month to obtain cell cultures from each biopsy. Approximately one month (not necessarily continuous) for in vitro experiments and analyses. Total: 60 days per sample

  • Efficiency of fibroblast epigenetic conversion (gene expression analysis)

    To determine whether cells from dysmetabolic individuals are different in term of epigenetic conversion efficiency when compared with control-derived cells.

    The epigenetic conversion protocol requires 25 days, the analysis of gene expression (qRTPCR) approximately 5 days.

  • Characterization of neural progenitors cells

    To determine whether neural progenitor cell (NPCs) obtained from dysmetabolic individuals are defective (analysis of degenerative features) when compared with control-derived cells.

    At the end of the epigenetic conversion, the cell cultures are "blocked" and analysed with biochemistry and molecular biology techniques whose protocols and data analysis require 30 days not necessarily continuous

Study Arms (4)

BMI<25 and T2DM

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

Other: Skin biopsy

BMI<25 without T2DM

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

Other: Skin biopsy

BMI>30 and T2DM

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

Other: Skin biopsy

BMI>30 without T2DM

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

Other: Skin biopsy

Interventions

Skin biopsyOTHER

Skin biopsy performed during surgery.

BMI<25 and T2DMBMI<25 without T2DMBMI>30 and T2DMBMI>30 without T2DM

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Malignant neoplastic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mingrone Geltrude

Roma, 00188, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityCognitive DysfunctionMetabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • geltrude mingrone

    Policlinico A. Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

January 1, 2020

Primary Completion

April 30, 2023

Study Completion

May 14, 2023

Last Updated

March 10, 2023

Record last verified: 2023-02

Locations

IT(1)