Age and Insulin Resistance

Obesity Clinical Trial

— AGIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01224886
• Other study ID #: AGIR
• Secondary ID: Protocol 188/10
• Status: Recruiting
• Phase: N/A
• Start date: October 2010
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: University of Lausanne
• Contact: Francesca Amati, MD, PhD
• Phone: +41 21 692 5552
• Email: francesca.amati[@]unil.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Insulin Resistance
• Obesity
• Physical Inactivity

Intervention

Behavioral:
• Physical activity
Supervised exercise intervention

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern
Switzerland	UNIL and CHUV	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Amati F, Broskey NT, Carnero EA. Evidence of systematic and proportional error in a widely used glucose oxidase analyser: impact for clinical research? Clin Endocrinol (Oxf). 2014 May;80(5):768-70. doi: 10.1111/cen.12274. Epub 2013 Jul 19. No abstract ava — View Citation

Broskey NT, Boss A, Fares EJ, Greggio C, Gremion G, Schluter L, Hans D, Kreis R, Boesch C, Amati F. Exercise efficiency relates with mitochondrial content and function in older adults. Physiol Rep. 2015 Jun;3(6):e12418. doi: 10.14814/phy2.12418. — View Citation

Broskey NT, Daraspe J, Humbel BM, Amati F. Skeletal muscle mitochondrial and lipid droplet content assessed with standardized grid sizes for stereology. J Appl Physiol (1985). 2013 Sep 1;115(5):765-70. doi: 10.1152/japplphysiol.00063.2013. Epub 2013 Jun 2 — View Citation

Broskey NT, Greggio C, Boss A, Boutant M, Dwyer A, Schlueter L, Hans D, Gremion G, Kreis R, Boesch C, Canto C, Amati F. Skeletal muscle mitochondria in the elderly: effects of physical fitness and exercise training. J Clin Endocrinol Metab. 2014 May;99(5) — View Citation

Greggio C, Jha P, Kulkarni SS, Lagarrigue S, Broskey NT, Boutant M, Wang X, Conde Alonso S, Ofori E, Auwerx J, Canto C, Amati F. Enhanced Respiratory Chain Supercomplex Formation in Response to Exercise in Human Skeletal Muscle. Cell Metab. 2017 Feb 7;25(2):301-311. doi: 10.1016/j.cmet.2016.11.004. Epub 2016 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		0-4 months
Primary	Ectopic lipids		0-4 months
Primary	Oxidative capacity		0-4 months
Secondary	Body composition		0-4 months
Secondary	Metabolic flexibility		0-4 months
Secondary	Exercise efficiency		0-4 months
Secondary	Physical fitness		0-4 months