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Age and Insulin Resistance (AGIR)

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ClinicalTrials.gov Identifier: NCT01224886
Recruitment Status : Recruiting
First Posted : October 20, 2010
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Francesca Amati, University of Lausanne

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Physical Inactivity Aging Behavioral: Physical activity Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In French AGIR Means to Get Into Action. This is the Generic Title of Our Study.
Study Start Date : October 2010
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sedentary obese Behavioral: Physical activity
Supervised exercise intervention
Experimental: Sedentary normal weight Behavioral: Physical activity
Supervised exercise intervention
No Intervention: Athletes


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224886


Contacts
Contact: Francesca Amati, MD, PhD +41 21 692 5552 francesca.amati@unil.ch

Locations
Switzerland
University of Bern Active, not recruiting
Bern, Switzerland
UNIL and CHUV Recruiting
Lausanne, Switzerland, 1005
Contact: Francesca Amati, MD, PhD    +41 21 692 5552    francesca.amati@unil.ch   
Principal Investigator: Francesca Amati, MD, PhD         
Sub-Investigator: Luc Tappy, MD         
Sponsors and Collaborators
University of Lausanne
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Francesca Amati, MD,PhD University of Lausanne
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Francesca Amati, Associate Professor, University of Lausanne
ClinicalTrials.gov Identifier: NCT01224886     History of Changes
Other Study ID Numbers: AGIR
Protocol 188/10 ( Other Identifier: Ethics committee )
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Francesca Amati, University of Lausanne:
Aging
Insulin resistance
Ectopic lipids
Obesity
Exercise
 Physical activity
Oxidative capacity
Diabetes
Metabolic syndrome

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases