Age and Insulin Resistance

NCT ID: NCT01224886

Last Updated: 2024-12-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2028-12-31

Brief Summary

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Insulin resistance is a crucial factor for the development of type 2 diabetes and a major health problem for older adults. It is the principal mechanism by which obesity is considered to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. The elevated prevalence of obesity and type 2 diabetes in the older population has important consequences on the morbidity and mortality as well as on the economic burden on society. Controversy currently exists as to whether or not aging contributes to insulin resistance. Many potential factors confound the association between aging and insulin resistance, including obesity and physical inactivity.

Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose tissues such as in the liver (intrahepatic lipids) and within the muscle fibers (intramyocellular lipids), are positively associated with obesity and insulin resistance. Furthermore, the accumulation of intracellular lipids is often cited as being a key determinant in the underlying mechanisms of insulin resistance. In addition of playing an important role in obesity and type 2 diabetes, these ectopic fat depositions are also observed in common conditions such as aging and physical inactivity.

The intervention trial will test in skeletal muscle, liver and heart of sedentary obese volunteers, normal weight volunteers and masters athletes, the overall hypotheses that exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is a primary factor that predicts the improvement in insulin resistance.

Detailed Description

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Conditions

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Obesity Physical Inactivity Aging

Keywords

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Aging Insulin resistance Ectopic lipids Obesity Exercise Physical activity Oxidative capacity Diabetes Metabolic syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sedentary obese

Group Type EXPERIMENTAL

Physical activity

Intervention Type BEHAVIORAL

Supervised exercise intervention

Sedentary normal weight

Group Type EXPERIMENTAL

Physical activity

Intervention Type BEHAVIORAL

Supervised exercise intervention

Athletes

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity

Supervised exercise intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 60-80
* Sedentary or highly trained
* BMI 18-40
* Non-Smoker
* Normal glucose tolerance or impaired glucose tolerance
* Willingness to comply with the protocol

Exclusion Criteria

* Contraindication to moderate exercise or clinical conditions precluding from joining an exercise program, such as clinically significant cardiovascular disease, peripheral vascular disease, uncontrolled hypertension, neurological or orthopedic disease
* Recent weight loss or weight gain
* Known diabetes
* Known drugs to affect glucose homeostasis such as nicotinic acid, glucocorticoids
* Severe anemia or lipid disturbances, hepatic or renal disease
* Recent history of cancer
* Hypothyroidism
* Recent hormone replacement therapy
* Known allergy to lidocaine or other local anesthetic
* Positive stress test
* Active alcohol or substance abuse
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Francesca Amati

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesca Amati, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Locations

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University of Bern

Bern, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

UNIL and CHUV

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Francesca Amati, MD, PhD

Role: CONTACT

Phone: +41 21 692 5552

Email: [email protected]

Facility Contacts

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Francesca Amati, MD, PhD

Role: primary

References

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Greggio C, Jha P, Kulkarni SS, Lagarrigue S, Broskey NT, Boutant M, Wang X, Conde Alonso S, Ofori E, Auwerx J, Canto C, Amati F. Enhanced Respiratory Chain Supercomplex Formation in Response to Exercise in Human Skeletal Muscle. Cell Metab. 2017 Feb 7;25(2):301-311. doi: 10.1016/j.cmet.2016.11.004. Epub 2016 Dec 1.

Reference Type BACKGROUND
PMID: 27916530 (View on PubMed)

Broskey NT, Boss A, Fares EJ, Greggio C, Gremion G, Schluter L, Hans D, Kreis R, Boesch C, Amati F. Exercise efficiency relates with mitochondrial content and function in older adults. Physiol Rep. 2015 Jun;3(6):e12418. doi: 10.14814/phy2.12418.

Reference Type RESULT
PMID: 26059033 (View on PubMed)

Broskey NT, Greggio C, Boss A, Boutant M, Dwyer A, Schlueter L, Hans D, Gremion G, Kreis R, Boesch C, Canto C, Amati F. Skeletal muscle mitochondria in the elderly: effects of physical fitness and exercise training. J Clin Endocrinol Metab. 2014 May;99(5):1852-61. doi: 10.1210/jc.2013-3983. Epub 2014 Jan 17.

Reference Type RESULT
PMID: 24438376 (View on PubMed)

Broskey NT, Daraspe J, Humbel BM, Amati F. Skeletal muscle mitochondrial and lipid droplet content assessed with standardized grid sizes for stereology. J Appl Physiol (1985). 2013 Sep 1;115(5):765-70. doi: 10.1152/japplphysiol.00063.2013. Epub 2013 Jun 20.

Reference Type RESULT
PMID: 23788579 (View on PubMed)

Amati F, Broskey NT, Carnero EA. Evidence of systematic and proportional error in a widely used glucose oxidase analyser: impact for clinical research? Clin Endocrinol (Oxf). 2014 May;80(5):768-70. doi: 10.1111/cen.12274. Epub 2013 Jul 19. No abstract available.

Reference Type RESULT
PMID: 23800101 (View on PubMed)

Other Identifiers

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Protocol 188/10

Identifier Type: OTHER

Identifier Source: secondary_id

AGIR

Identifier Type: -

Identifier Source: org_study_id