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Inflammatory Axis and Sirtuins' in Overweight Pre-diabetics Patients

NCT03491241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-01

No results posted yet for this study

Summary

In obese patients the superficial adipose tissue works as an endocrine active tissue to express different cytokines, and multiple molecular pathways implied in the cross talking with different part of the human body, such as the cardiovascular system. To date, adipocytes and adipose tissue-derived macrophages and adipose tissue synthesize, and secrete several cytokines, and sirtuins. In this setting, the excess of body fat is linked to heart contractile dysfunction. All these pathways are differently expressed in obese diabetic patients as compared to obese non diabetic patients. Intriguingly, in diabetic obese patients the hyper-expression of inflammatory cytokines is associated to a hypo-expression of sirtuins. Furthermore, microRNAs (miRs) as miR 195 and miR 27 could be implied in the regulation of this complex cellular and molecular axis.Therefore, this molecular pattern in diabetic obese patients may correlate to altered myocardial performance, and to the development of heart failure disease. In this study authors will evaluate at baseline by peripheral blood samples and by the abdominal fat tissue, and than at 12 months of follow-up by perupheral blood analysis, the expression of cytokines sirtuins and miR 195/27 comparing pre-diabetics obese patients vs. non pre-diabetics obese patients.

Conditions

Interventions

DIETARY_SUPPLEMENT

hypocaloric diet therapy

all patients will receive an hypocaloric diet, with low carboidrates (\<50%) overload.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-11-01
Completion
2018-01-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03491241 on ClinicalTrials.gov