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Inflammatory Axis and Sirtuins' in Overweight Pre-diabetics Patients

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ClinicalTrials.gov Identifier: NCT03491241
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

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. 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, the expression of cytokines and sirtuins comparing pre-diabetics obese patients vs. non pre-diabetics obese patients.

Condition or disease Intervention/treatment Phase
Pre-diabetes Obesity Dietary Supplement: hypocaloric diet therapy Not Applicable

Detailed Description:
In obese patients the visceral fat, and the superficial adipose tissue work 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, like tumor necrosis factor (TNF)-5 and interleukin (IL)-6, and anti-apoptotic proteins, such as sirtuins. Sirtuins are NAD+-dependent deacetylase involved in the control of energy metabolism, adipocyte hypertrophy, and of different cardiac reparative, and rimodellative functions. In this setting, the excess of body fat is linked to heart contractile dysfunction. It is intuitive to speculate that, 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. Therefore, this molecular pattern in diabetic obese patients may correlate to altered myocardial performance, and to the development of heart failure disease. Authors' study hypothesis is that, this complex altered bidirectional pattern between the inflammatory and apoptotic pathways axis may be due to a progressive increase in adipose tissue, produced by long-term alterations in energy balance. However, all these alterations may be measured in adipocytes as well as in adipose tissue derived macrophages, and by peripheral blood assay. Intriguingly, no data evaluated these pathways in pre-diabetics obese patients, and their possible correlation to cardiac function worsening, and to the development of heart failure disease. Actually, the pre-diabetic obese subjects represent a population of patients associated to higher risk to develop cardiovascular disease, myocardial dysfunction, and heart failure. In these patients a not clear indication exists about the right dietetic and/or drug treatment to control the hyperglycemia. However, there is discussion about the necessity or not to introduce hypoglycemic drug therapy added to a hypocaloric diet therapy to control the hyperglycemic overload. Therefore, the aim of the present study will be to evaluate at baseline the abdominal fat tissue expression of cytokines and sirtuins (by direct tissue biopsy) and by peripheral blood samples in pre-diabetics obese patients vs. non pre-diabetics obese patients. As second, during six and twelve months of follow up by peripheral blood samples analysis authors will evaluate the abdominal fat tissue expression of cytokines and sirtuins in pre-diabetics obese patients treated by hypocaloric diet-therapy as compared to pre-diabetics obese patients treated by hypocaloric diet-therapy plus metformine. At the end, authors will report their correlation to myocardial performance index (MPI) as an index of myocardial performance in pre-diabetics obese patients treated by hypocaloric diet-therapy as compared to pre-diabetics obese patients treated by hypocaloric diet-therapy plus metformine. Authors may speculate to observe a different cytokines and sirtuins expression at visceral fat and peripheral blood in pre-diabetics obese patients vs. non pre-diabetics obese patients. As second, authors may find that, hypoglycemic drug therapy may induce a down regulation of peripheral blood cytokines, and a hyper expression of sirtuins involved in the control of energy metabolism, and of adipocyte hypertrophy, and secondary implied in a better cardiac function at follow up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Effect of Inflammatory Axis and Sirtuins' Expression in a Population of Overweight Pre-diabetics Patients From Metabolic Homeostasis Towards the Adipogonesis, and to Cardiac Redomelling.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: pre-diabetics obese patients
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
all patients will receive an hypocaloric diet, with low carboidrates (<50%) overload.

Placebo Comparator: pre-diabetics patients
These pre-diabetic patients will be treated by hypocaloric diet therapy alone.
Dietary Supplement: hypocaloric diet therapy
all patients will receive an hypocaloric diet, with low carboidrates (<50%) overload.

Active Comparator: obese patients
These obese patients will be treated by hypocaloric diet therapy.
Dietary Supplement: hypocaloric diet therapy
all patients will receive an hypocaloric diet, with low carboidrates (<50%) overload.




Primary Outcome Measures :
  1. left ventricle ejection fraction [ Time Frame: 12 months ]
    authors will assess left ventricle ejection fraction by trans thoracic bidimensional echocardiographic measurements.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491241


Locations
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Italy
Raffaele Marfella
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

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Responsible Party: Celestino Sardu, Principal investigator, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03491241    
Other Study ID Numbers: 22.3.2018
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases