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ObesityNCT00971594

Age, Lifestyle, Muscle Mechanisms in Insulin Resistance

A study testing Dietary counseling and AEX in people with Obesity and Glucose Intolerance, run by National Institute on Aging (NIA) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the mechanisms by which physical inactivity and obesity alter skeletal muscle insulin signaling to cause insulin resistance and increase the development of impaired glucose tolerance (IGT). Read more about this study

Who is it for?
Ages 50 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Glucose Intolerance, Exercise Capacity
What is being tested?
Dietary counseling and AEX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
Jun 2004to May 2008
Phase
Interventional
Are there results?
None posted in the registry

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 50 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men older than 50 yrs of age
  • Non-smoking (more than 5 years)
  • BMI greater than 25 kg/m2 and less than 50 kg/m2

Who cannot join

  • CAD, CHF, Myocardial infarction within 6 months or other symptomatic heart disease
  • History of stroke, peripheral arterial disease
  • Currently being treated for active cancer
  • On oral agents or insulin therapy for diabetes
  • Poorly controlled Dyslipidemia (abnormal concentration of lipids or lipoproteins in the blood)
  • Poorly controlled hypertension (BP > 180/95)
Show all 16Show fewer
  • Other systematic disorders that are not medically treated and stable
  • Physical impairment limiting normal activity and other contraindications to exercise
  • Aerobically conditioned
  • Abnormal response to exercise (chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP > 240/120)
  • Taking warfarin/coumadin
  • Taking oral steroids
  • Abnormal renal function or liver function
  • Chronic pulmonary disease severe enough to require oxygen
  • Anemia
  • MMSE < 24, dementia

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baltimore VA Medical Center

    Baltimore, Maryland, 21201

  • University of Maryland

    Baltimore, Maryland, 21201

Other trials in United States

About this study

The purpose of this study is to investigate the mechanisms by which physical inactivity and obesity alter skeletal muscle insulin signaling to cause insulin resistance and increase the development of impaired glucose tolerance (IGT).

Read the detailed description

Aging is associated with a progressive development of impaired glucose tolerance (IGT), due to an increased peripheral tissue resistance to the action of insulin. Insulin resistance, a common state in both obese and sedentary individuals, eventually leads to the development of glucose intolerance, and type 2 diabetes with aging. Even in the absence of diabetes, insulin resistance is a key feature in various metabolic abnormalities that increase the risk for developing cardiovascular disease (CVD). Previous studies demonstrate improvements in glucose tolerance and glucose utilization following moderate energy restriction coupled with moderate intensity AEX. WL, through behavioral modification of diet and aerobic exercise (AEX), is perhaps the most effective way to treat as well as prevent insulin resistance and its associated metabolic complications of IGT and type 2 diabetes. Although these studies demonstrate the beneficial effect of weight loss (WL) and AEX on glucose tolerance and insulin action, not much is known about the cellular and molecular mechanisms by which these nonpharmacologic treatments improve glucose utilization in high-risk obese older individuals.

This study seeks to determine the cellular mechanisms by which aerobic exercise and weight loss alter skeletal muscle insulin signaling to improve insulin action in older glucose intolerant individuals. A second purpose is to determine whether certain genes (hereditary information) affect the way the body utilizes glucose in response to exercise and weight loss. In addition, adipose tissue is increasingly recognized as more than an inert depot serving not only to accept and store excess energy in the form of triglycerides, but also to secrete hormones and adipokines that have substantial effects on lipid and glucose metabolism. Furthermore, there are depot differences in metabolic function, as well as adipokine content. However, the physiology both underlying and consequential to these observations remains unknown. Thus, a third aim is to examine the effects of obesity on regional adipokine secretion and expression, and the relationship of adipokines to insulin resistance and the metabolic syndrome.

Being tested
Dietary counseling, AEX
Keywords
weight loss, glucose metabolism
Medical subject headings
Obesity, Glucose Intolerance, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary counselingBehavioural

    1 hour sessions, once per week, with a registered dietitian on the American Heart Association Step I diet with caloric intake for each volunteer adjusted by the dietitian to elicit a WL of ~0.2-0.4 kg/wk

  • AEXBehavioural

    Moderate aerobic exercise (75-80% HRR for 45 min) at the Baltimore GRECC exercise facility using treadmills 3 times per week for 6 months.

Study groups in NCT00971594
Study groupRoleWhat they receive
WL+AEXExperimentalWeight loss plus aerobic exercise
Receives: Behavioral: Dietary counseling; Behavioral: AEX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin stimulated glucose disposal

    Measured: Baseline and 6 months

  2. Content and activity of insulin signaling proteins from muscle biopsies

    Measured: Baseline and 6 months

  3. Glucose tolerance

    Measured: Baseline and 6 months

Secondary outcomes (4)

  1. Aerobic capacity

    Measured: Baseline and 6 months

  2. Body weight/Composition

    Measured: Baseline and 6 months

  3. Cytokines

    Measured: Baseline and 6 months

  4. Other biomarkers (such as glucose, insulin etc)

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2009 (estimated)
  2. Study startJun 2004
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971594
Sponsor's protocol ID
AG0120
Other IDs
K01AG021457
Status last verified
Sep 2009
First submitted
2 Sep 2009
Last updated
3 Sep 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

  • Houmard JA, Tanner CJ, Slentz CA, Duscha BD, McCartney JS, Kraus WE. Effect of the volume and intensity of exercise training on insulin sensitivity. J Appl Physiol (1985). 2004 Jan;96(1):101-6. doi: 10.1152/japplphysiol.00707.2003. Epub 2003 Sep 12.

    PubMed 12972442

  • Deshmukh AS, Hawley JA, Zierath JR. Exercise-induced phospho-proteins in skeletal muscle. Int J Obes (Lond). 2008 Sep;32 Suppl 4:S18-23. doi: 10.1038/ijo.2008.118.

    PubMed 18719593

  • Catenacci VA, Hill JO, Wyatt HR. The obesity epidemic. Clin Chest Med. 2009 Sep;30(3):415-44, vii. doi: 10.1016/j.ccm.2009.05.001.

    PubMed 19700042

  • Prior SJ, Blumenthal JB, Katzel LI, Goldberg AP, Ryan AS. Increased skeletal muscle capillarization after aerobic exercise training and weight loss improves insulin sensitivity in adults with IGT. Diabetes Care. 2014 May;37(5):1469-75. doi: 10.2337/dc13-2358. Epub 2014 Mar 4.

    PubMed 24595633

Questions about this trial

What is this clinical trial studying?

A study testing Dietary counseling and AEX in people with Obesity and Glucose Intolerance, run by National Institute on Aging (NIA) at 2 sites in United States.

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 3 inclusion and 16 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: finished, as of the sponsor's last update on 3 Sep 2009. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin stimulated glucose disposal (time frame: Baseline and 6 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 NCT00971594, 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 3 Sep 2009.

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