Inflammatory Axis and Sirtuins' in Overweight Pre-diabetics Patients

NCT03491241 | Completed DMC

• 1 other identifier: 22.3.2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Pre-diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• left ventricle ejection fraction

  authors will assess left ventricle ejection fraction by trans thoracic bidimensional echocardiographic measurements.

  12 months

Study Arms (3)

pre-diabetics obese patients

EXPERIMENTAL

These pre-diabetic obese patients will be treated by hypocaloric diet therapy. these patients were under metformine therapy at enrollment.

Dietary Supplement: hypocaloric diet therapy

pre-diabetics patients

PLACEBO COMPARATOR

These pre-diabetic patients will be treated by hypocaloric diet therapy alone.

Dietary Supplement: hypocaloric diet therapy

obese patients

ACTIVE COMPARATOR

These obese patients will be treated by hypocaloric diet therapy.

Dietary Supplement: hypocaloric diet therapy

Interventions

hypocaloric diet therapy DIETARY_SUPPLEMENT

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

obese patients; pre-diabetics obese patients; pre-diabetics patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• body mass index \> 30;
• prediabetes;
• normal glycemic blood profile;
• both gender;
• age \> 18 and \< 65 years old.

You may not qualify if:

• body mass index \< 30;
• diabetes;
• age \< 18, and \> 65 years old.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 9, 2018
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

IT (1)