NCT04106570

Brief Summary

Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

September 25, 2019

Last Update Submit

October 17, 2023

Conditions

Keywords

ObeseTorque productionNeuromuscular fatigueElectrical muscle stimulationKnee extensorsMetabolic disorders

Outcome Measures

Primary Outcomes (2)

  • Maximal torqueof the knee extensors (in N.m)

    Maximal torque of the knee extensors (in N.m) measured with a dynamometer.

    day 7

  • Fatiguability of the knee extensors (in N.m)

    Fatiguability of the knee extensors (in N.m) measured with a dynamometer.

    day 7

Secondary Outcomes (21)

  • Maximal muscle power of the lower limb

    day 1

  • Functional capacity

    day 1

  • Muscle contractile properties

    day 7

  • Measure of alteration of the excitation contraction coupling

    day 7

  • Measure of Sarcolemma excitability

    day 7

  • +16 more secondary outcomes

Study Arms (6)

YOMH

EXPERIMENTAL

Young obese metabolically healthy Description: Aged from 20 to 40 years old and with a glycemia \< 1g/l and a triglyceridemia \< 1,5g/l.

Other: fatiguability of the knee extensors

YOMD

EXPERIMENTAL

Young obese with metabolic disorders Description: Aged from 20 to 40 years old and with a glycemia \> 1g/l and a triglyceridemia \> 1,5g/l.

Other: fatiguability of the knee extensors

MAOMH

EXPERIMENTAL

Middle-Age obese metabolically healthy Description: Aged from 40 to 50 years old and with a glycemia \< 1g/l and a triglyceridemia \< 1,5g/l.

Other: fatiguability of the knee extensors

MAOMD

EXPERIMENTAL

Middle-Age obese with metabolic disorders Description: Aged from 40 to 50 years old and with a glycemia \> 1g/l and a triglyceridemia \> 1,5g/l.

Other: fatiguability of the knee extensors

EOMH

EXPERIMENTAL

Elderly obese metabolically healthy Description: Aged from 50 to 70 years old and with a glycemia \< 1g/l and a triglyceridemia \< 1,5g/l.

Other: fatiguability of the knee extensors

EOMD

EXPERIMENTAL

Elderly obese with metabolic disorders Description: Aged from 50 to 70 years old and with a glycemia \> 1g/l and a triglyceridemia \> 1,5g/l.

Other: fatiguability of the knee extensors

Interventions

fatiguability of the knee extensors (in N.m) measured with a dynamometer.

EOMDEOMHMAOMDMAOMHYOMDYOMH

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male subject, aged between 20 and 70 years old (inclusive terminals).
  • Subject with a BMI greater than 30kg/m².
  • Subject with a stable weight for at least 3 months before the start of the study.
  • Subject capable and willing to comply with the protocol and willing to give informed consent in writing.
  • Subject affiliated to a social security system.

You may not qualify if:

  • Subject with a medical or surgical history deemed by the investigator to be incompatible with the study.
  • Subject with a medical contraindication to intense activity.
  • Subject weighing more than 170kg, which may damage the dynamometer chair.
  • Subject who has received a total amount of compensation since the beginning of the calendar year, greater than 4500 euros (amount may change depending on the regulation).
  • Subject with a linguistic or physiological disability to sign informed consent.
  • Subject deprived of liberty by administrative of juridical decision, under guardianship or curatorship.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

ObesityMetabolic Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yves Boirie

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

December 2, 2019

Primary Completion

June 26, 2023

Study Completion

June 26, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations