Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age

NCT ID: NCT02161926

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-02-28

Brief Summary

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The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.

The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.

Detailed Description

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Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men.

Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. All those endpoints are studied comparing elderly obese subjects versus young obese subjects.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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obese men from 60 to 70 years old

Dietary restrictions in obese men (30\<Body Mass Index\<40 kg/m2)

Group Type EXPERIMENTAL

dietary restrictions

Intervention Type OTHER

Dietary restrictions during 8 weeks

obese men from 30 to 40 years old

Dietary restrictions in obese men (30\<Body Mass Index\<40 kg/m2)

Group Type ACTIVE_COMPARATOR

dietary restrictions

Intervention Type OTHER

Dietary restrictions during 8 weeks

Interventions

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dietary restrictions

Dietary restrictions during 8 weeks

Intervention Type OTHER

Other Intervention Names

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Dietary restrictions (20 % dietary restrictions)

Eligibility Criteria

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Inclusion Criteria

* 30 \< years old \< 40 OR 60 \< years old \< 70
* obesity : 30 \< BMI \< 40
* stable blood pressure (diastolic \<90mmHg, systolic \< 140mmHg)
* glycemia \< 1,26g/L, LDL cholest \<1,9-1,6g/L, Triglycerides \<2,5g/L
* risk factors concerning high blood pressure, diabetes and dyslipidemia under control

Exclusion Criteria

* Insulin dependent diabetes, non-insulin dependent diabetes
* high blood pressure
* dyslipidemia
* history of cardiovascular diseases or bariatric surgery
* undernutrition
* HbA1C \>7%
* non authorized treatments : Glucagon-like peptide-1 agonists,
* incapacity to do physical activity
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Thalamas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01543-42

Identifier Type: OTHER

Identifier Source: secondary_id

13 149 03

Identifier Type: -

Identifier Source: org_study_id

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