NCT01224886

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
31mo left

Started Oct 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2010Dec 2028

Study Start

First participant enrolled

October 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
18.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

18.2 years

First QC Date

October 14, 2010

Last Update Submit

December 4, 2024

Conditions

ObesityPhysical InactivityAging

Keywords

AgingInsulin resistanceEctopic lipidsObesityExercisePhysical activityOxidative capacityDiabetesMetabolic syndrome

Outcome Measures

Primary Outcomes (3)

  • Insulin sensitivity

    0-4 months

  • Ectopic lipids

    0-4 months

  • Oxidative capacity

    0-4 months

Secondary Outcomes (4)

  • Body composition

    0-4 months

  • Metabolic flexibility

    0-4 months

  • Exercise efficiency

    0-4 months

  • Physical fitness

    0-4 months

Study Arms (3)

Sedentary obese

EXPERIMENTAL
Behavioral: Physical activity

Sedentary normal weight

EXPERIMENTAL
Behavioral: Physical activity

Athletes

NO INTERVENTION

Interventions

Physical activityBEHAVIORAL

Supervised exercise intervention

Sedentary normal weightSedentary obese

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Bern

Bern, Switzerland

ACTIVE NOT RECRUITING

UNIL and CHUV

Lausanne, 1005, Switzerland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27916530BACKGROUND

  • 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.

    PMID: 26059033RESULT

  • 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):1852-61. doi: 10.1210/jc.2013-3983. Epub 2014 Jan 17.

    PMID: 24438376RESULT

  • 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 20.

    PMID: 23788579RESULT

  • 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 available.

    PMID: 23800101RESULT

MeSH Terms

Conditions

ObesitySedentary BehaviorInsulin ResistanceMotor ActivityDiabetes MellitusMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Francesca Amati, MD,PhD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Amati, MD, PhD

CONTACT

+41 21 692 5552francesca.amati@unil.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 20, 2010

Study Start

October 1, 2010

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)