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Clinical Trial NCT01224886 (AGIR) for Obesity, Physical Inactivity, Aging is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Age and Insulin Resistance (AGIR)

Recruiting
Clinical Trial NCT01224886 (AGIR) is an interventional study for Obesity, Physical Inactivity, Aging that is recruiting. It started on October 1, 2010 with plans to enroll 150 participants. Led by University of Lausanne, it is expected to complete by December 1, 2028. The latest data from ClinicalTrials.gov was last updated on December 5, 2024.
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.

Official Title

In French AGIR Means to Get Into Action. This is the Generic Title of Our Study.

Conditions
ObesityPhysical InactivityAging
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • AGIR
  • Protocol 188/10 (Other Identifier) (Ethics committee)
NCT ID Number
Start Date (Actual)
2010-10
Last Update Posted
2024-12-05
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Aging
Insulin resistance
Ectopic lipids
Obesity
Exercise
Physical activity
Oxidative capacity
Diabetes
Metabolic syndrome
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSedentary obese
Physical Activity
Supervised exercise intervention
ExperimentalSedentary normal weight
Physical Activity
Supervised exercise intervention
No InterventionAthletes
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Insulin sensitivity
0-4 months
Ectopic lipids
0-4 months
Oxidative capacity
0-4 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Body composition
0-4 months
Metabolic flexibility
0-4 months
Exercise efficiency
0-4 months
Physical fitness
0-4 months
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
60 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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
University of Lausanne logoUniversity of Lausanne
Centre Hospitalier Universitaire Vaudois logoCentre Hospitalier Universitaire Vaudois
Study Responsible Party
Francesca Amati, Principal Investigator, Associate Professor, University of Lausanne
Study Central Contact
Contact: Francesca Amati, MD, PhD, +41 21 692 5552, [email protected]
2 Study Locations in 1 Countries
University of Bern, Bern, Switzerland
Active, not recruiting
UNIL and CHUV, Lausanne, 1005, Switzerland
Francesca Amati, MD, PhD, Contact, +41 21 692 5552, [email protected]
Francesca Amati, MD, PhD, Principal Investigator
Luc Tappy, MD, Sub-Investigator
Recruiting