Age and Insulin Resistance (AGIR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Lausanne.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by:
University of Lausanne
ClinicalTrials.gov Identifier:
NCT01224886
First received: October 14, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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 Intervention
Obesity
Physical Inactivity
Aging
Behavioral: Physical activity

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Resistance of Aging, Ectopic Lipid Depositions and Oxidative Capacity: Effects of Exercise and Obesity

Resource links provided by NLM:


Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]
  • Ectopic lipids [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]
  • Oxidative capacity [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]
  • Metabolic flexibility [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]
  • Exercise efficiency [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]
  • Physical fitness [ Time Frame: 0-4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sedentary obese Behavioral: Physical activity
Supervised exercise intervention
Experimental: Sedentary normal weight Behavioral: Physical activity
Supervised exercise intervention
No Intervention: Athletes

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Francesca Amati, MD, PhD, University of Lausanne
ClinicalTrials.gov Identifier: NCT01224886     History of Changes
Other Study ID Numbers: SNSF PZ00P3_126339, Protocol 188/10
Study First Received: October 14, 2010
Last Updated: August 4, 2011
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Insulin Resistance
Insulin
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014