Age and Insulin Resistance (AGIR)
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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 |
- 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 ]
- 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: | 150 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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:
- 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01224886
| Contact: Francesca Amati, MD, PhD | +41 21 692 5552 | francesca.amati@unil.ch |
| 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 | |
| Principal Investigator: | Francesca Amati, MD,PhD | University of Lausanne |
More Information
| Responsible Party: | Francesca Amati, Associate Professor, University of Lausanne |
| ClinicalTrials.gov Identifier: | NCT01224886 History of Changes |
| Other Study ID Numbers: | AGIR Protocol 188/10 |
| Study First Received: | October 14, 2010 |
| Last Updated: | December 24, 2015 |
| 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 Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016