Age and Insulin Resistance (AGIR)

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by University of Lausanne

Sponsor:

Collaborator:

Centre Hospitalier Universitaire Vaudois

Information provided by (Responsible Party):

Francesca Amati, University of Lausanne

ClinicalTrials.gov Identifier:

NCT01224886

First received: October 14, 2010

Last updated: December 1, 2014

Last verified: December 2014

History of Changes

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:

MedlinePlus related topics: Diabetes Medicines Exercise and Physical Fitness Health Checkup

Drug Information available for: Insulin

U.S. FDA Resources

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:	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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Associate Professor, 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:	December 1, 2014
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 Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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