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RecruitingNCT01224886AGIRUpdated Dec 5, 2024

Age and Insulin Resistance

An interventional study of Physical activity in Obesity, Physical Inactivity and Aging, sponsored by University of Lausanne. Recruiting at 2 sites in Switzerland. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by University of Lausanne · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
60 Years to 80 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Obesity
  • Physical Inactivity
  • Aging

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Keywords

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

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's planned enrollment of 150 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Lausanne is the lead sponsor of 54 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Sedentary obese

    Behavioral: Physical activity

  • Experimental
    Sedentary normal weight

    Behavioral: Physical activity

  • No intervention
    Athletes

Interventions

  • BehavioralPhysical activity

    Supervised exercise intervention

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What researchers measure

Primary outcomes

  1. Insulin sensitivity

    Time frame: 0-4 months

  2. Ectopic lipids

    Time frame: 0-4 months

  3. Oxidative capacity

    Time frame: 0-4 months

Secondary outcomes

  1. Body composition

    Time frame: 0-4 months

  2. Metabolic flexibility

    Time frame: 0-4 months

  3. Exercise efficiency

    Time frame: 0-4 months

  4. Physical fitness

    Time frame: 0-4 months

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Study locations

1 of 2 sites recruiting
  • University of Bern
    Bern, Switzerland
    Active, not recruiting
  • UNIL and CHUV
    Lausanne, 1005, Switzerland
    • Francesca Amati, MD, PhD · Contact · francesca.amati@unil.ch · +41 21 692 5552
    • Francesca Amati, MD, PhD · Principal investigator
    • Luc Tappy, MD · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 27916530 ↗
  • 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. PubMed 26059033 ↗
  • 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. PubMed 24438376 ↗
  • 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. PubMed 23788579 ↗
  • 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. PubMed 23800101 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01224886
Lead sponsor
University of Lausanne
Collaborators
Centre Hospitalier Universitaire Vaudois
Responsible party
Francesca Amati (Associate Professor, University of Lausanne) — Principal investigator
First posted
Oct 20, 2010
Start date
Oct 2010
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Dec 5, 2024

Study contacts

Francesca Amati, MD, PhD
Contact
francesca.amati@unil.ch
+41 21 692 5552
Francesca Amati, MD,PhD
principal investigator · University of Lausanne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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