Age and Insulin Resistance (AGIR)

November 28, 2023 updated by: Francesca Amati, University of Lausanne

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland
        • Active, not recruiting
        • University of Bern
      • Lausanne, Switzerland, 1005
        • Recruiting
        • UNIL and CHUV
        • Contact:
        • Principal Investigator:
          • Francesca Amati, MD, PhD
        • Sub-Investigator:
          • Luc Tappy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedentary obese
Behavioral: Physical activity
Supervised exercise intervention
Experimental: Sedentary normal weight
Behavioral: Physical activity
Supervised exercise intervention
No Intervention: Athletes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity
Time Frame: 0-4 months
0-4 months
Ectopic lipids
Time Frame: 0-4 months
0-4 months
Oxidative capacity
Time Frame: 0-4 months
0-4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 0-4 months
0-4 months
Metabolic flexibility
Time Frame: 0-4 months
0-4 months
Exercise efficiency
Time Frame: 0-4 months
0-4 months
Physical fitness
Time Frame: 0-4 months
0-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne

Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Francesca Amati, MD,PhD, University of Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimated)

October 20, 2010

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGIR
  • Protocol 188/10 (Other Identifier: Ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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