ObesityAGIRNCT01224886
Age and Insulin Resistance
A study testing Physical activity in people with Obesity and Physical Inactivity, run by University of Lausanne at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Inactivity, Aging
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Oct 2010to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Hypothyroidism
- Recent hormone replacement therapy
- Known allergy to lidocaine or other local anesthetic
- Positive stress test
- Active alcohol or substance abuse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 1 recruiting
- Active, not recruiting
University of Bern
Bern
- Recruiting
UNIL and CHUV
Lausanne, 1005
Francesca Amati, MD, PhD, +41 21 692 5552, francesca.amati@unil.ch
Francesca Amati, MD, PhD
About this study
Official title: 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.
- Conditions
- Obesity, Physical Inactivity, Aging
- Being tested
- Physical activity
- Keywords
- Aging, Insulin resistance, Ectopic lipids, Obesity, Exercise, Physical activity, Oxidative capacity, Diabetes, Metabolic syndrome
- Medical subject headings
- Obesity, Sedentary Behavior, Insulin Resistance, Motor Activity, Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Supervised exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Sedentary obese | Experimental | Not described Receives: Behavioral: Physical activity |
| Sedentary normal weight | Experimental | Not described Receives: Behavioral: Physical activity |
| Athletes | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: 0-4 months
Ectopic lipids
Measured: 0-4 months
Oxidative capacity
Measured: 0-4 months
Secondary outcomes (4)
Body composition
Measured: 0-4 months
Metabolic flexibility
Measured: 0-4 months
Exercise efficiency
Measured: 0-4 months
Physical fitness
Measured: 0-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Francesca Amati, University of Lausanne
- Investigators
- Francesca Amati, MD,PhD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224886
- Sponsor's protocol ID
- AGIR
- Other IDs
- Protocol 188/10
- Acronym
- AGIR
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2010
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27916530Broskey 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.
PubMed 26059033Broskey 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):1852-61. doi: 10.1210/jc.2013-3983. Epub 2014 Jan 17.
PubMed 24438376Broskey 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 20.
PubMed 23788579Amati 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 available.
PubMed 23800101
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In French AGIR Means to Get Into Action. This is the Generic Title of Our Study.
- ClinicalTrials.gov ID
- NCT01224886
- Acronym / sponsor ID
- AGIR / AGIR
- Conditions
- Obesity, Physical Inactivity, Aging
- Keywords
- Aging, Insulin resistance, Ectopic lipids, Obesity, Exercise, Physical activity, Oxidative capacity, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Oct 2010
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sedentary obese | Experimental | Behavioral: Physical activity |
| Sedentary normal weight | Experimental | Behavioral: Physical activity |
| Athletes | No intervention | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60-80
- Sedentary or highly trained
- BMI 18-40
- Non-Smoker
- Normal glucose tolerance or impaired glucose tolerance
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activitySupervised exercise intervention | Behavioural | Sedentary normal weight, Sedentary obese |
Primary outcome
Insulin sensitivity
Time frame: 0-4 months
Ectopic lipids
Time frame: 0-4 months
Oxidative capacity
Time frame: 0-4 months
4 secondary outcomes
Body composition
Time frame: 0-4 months
Metabolic flexibility
Time frame: 0-4 months
Exercise efficiency
Time frame: 0-4 months
Physical fitness
Time frame: 0-4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 27916530Greggio 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.
- Results publication: PubMed 26059033Broskey 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.
- Results publication: PubMed 24438376Broskey 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):1852-61. doi: 10.1210/jc.2013-3983. Epub 2014 Jan 17.
- Results publication: PubMed 23788579Broskey 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 20.
- Results publication: PubMed 23800101Amati 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 available.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Amati, MD,PhD principal investigator
University of Lausanne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Obesity and Physical Inactivity, run by University of Lausanne at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Amati, MD, PhD (+41 21 692 5552, francesca.amati@unil.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 0-4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224886, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.