Age, Lifestyle, Muscle Mechanisms in Insulin Resistance

NCT00971594 | Completed DMC

• 2 other identifiers: AG0120K01AG021457
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Obesity; Glucose Intolerance; Exercise Capacity

Keywords

weight loss; glucose metabolism

Outcome Measures

Primary Outcomes (3)

• Insulin stimulated glucose disposal

  Baseline and 6 months

• Content and activity of insulin signaling proteins from muscle biopsies

  Baseline and 6 months

• Glucose tolerance

  Baseline and 6 months

Secondary Outcomes (4)

• Aerobic capacity

  Baseline and 6 months

• Body weight/Composition

  Baseline and 6 months

• Cytokines

  Baseline and 6 months

• Other biomarkers (such as glucose, insulin etc)

  Baseline and 6 months

Study Arms (1)

WL+AEX

EXPERIMENTAL

Weight loss plus aerobic exercise

Behavioral: Dietary counseling; Behavioral: AEX

Interventions

Dietary counseling BEHAVIORAL

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

WL+AEX

AEX BEHAVIORAL

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

WL+AEX

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (2)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (5)

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 12972442 BACKGROUND

• 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.

  PMID: 18719593 BACKGROUND

• 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.

  PMID: 19700042 BACKGROUND

• 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.

  PMID: 24595633 DERIVED

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Weight Loss

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lyndon Joseph, PhD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: June 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 3, 2009

Record last verified: 2009-09

Locations

US (2)