NCT03175601

Brief Summary

The general objective of this study is to identify biomarkers of sleep quality, sarcopenia, insulin resistance, oxidative stress and inflammation associated with prefrailty in middle-aged and elderly obese subjects through the integrated study of sleep patterns, functional cardiovascular testing, olfactory function and circulating molecules. Results from the SleSOB study will contribute to identify molecular and functional determinants of prefrailty, to allow early targeted interventions and will have important implications for empowerment of elderly citizens to self-management of preventive measures and healthy lifestyle.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

June 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 1, 2017

Last Update Submit

June 2, 2017

Conditions

Sarcopenic Obesity

Keywords

Sleep disturbancesBiomarkersPrefrailtyInsulin resistanceOlfactory impairmentMultiplex arrayGait speed

Outcome Measures

Primary Outcomes (1)

  • Prevalence of prefrailty

    Proportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity

    Day one

Secondary Outcomes (18)

  • Prevalence of sarcopenia

    Day one

  • Cardiometabolic risk profile: insulin resistance

    Day one

  • Cardiometabolic risk profile: fatty liver

    Day one

  • Cardiometabolic risk profile: 10-year cardiovascular risk

    Day one

  • Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD)

    Day one

  • +13 more secondary outcomes

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Middle-aged and young-old obese subjects will be enrolled at a specialised nutrition clinic. Subjects will be on a maintenance weight management program including lifestyle advice and diet based on the principles of the Modern Mediterranean Diet Pyramid (variety in food choices, seasonality and spices to flavor dishes). The diet is modified to avoid high caloric food and distributed in 3 main meals and 2 healthy snacks during the day to provide a caloric intake of 28-30 kcal/die/kg body weight and macronutrient breakdown as recommended by INRAN (http://www.inran.it/) (Protein 15%, Fat \< 30%, carbohydrates 55/60% of which soluble 10-12 % and fiber 30 g die).

You may qualify if:

  • Obesity : body mass index ≥ 30 and \<40 kg/m2
  • Written informed consent

You may not qualify if:

  • Diabetes requiring insulin treatment
  • Stage IV chronic kidney dysfunction (estimated glomerular filtration rate \<15 ml/min)
  • Liver dysfunction (AST- ALT x 2 times upper normalcy range)
  • Active neoplasms
  • Claustrophobia
  • Psychiatric morbidity or any other condition that impairs the ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Fisiologia Clinica del CNR UOS Milano

Milan, 20162, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and urine samples

MeSH Terms

Conditions

ParasomniasInsulin ResistanceOlfaction Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Giovanna Trivella, MD

    Istituto di Fisiologia Clinica CNR

    PRINCIPAL INVESTIGATOR

  • Jonica Campolo, MSc

    Istituto di Fisiologia Clinica CNR

    STUDY DIRECTOR

Central Study Contacts

Renata De Maria, MD

CONTACT

+390266101344renata.demaria@ospedaleniguarda.it

Jonica Campolo, MSc

CONTACT

+39026473407jonica.campolo@ospedaleniguarda.it

Study Design

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

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 5, 2017

Study Start

June 1, 2017

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)