Exercise and Inflammation in the Elderly

NCT00753363 | Completed Results DMC

• 1 other identifier: AGCG-003-05F
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent low-grade inflammation and impaired fibrinolysis, are independent predictors of several chronic diseases highly prevalent in the older Veteran population including cardiovascular disease (CVD), stroke, and diabetes. Inflammation is likely to be a causative underlying mechanism of insulin resistance. Lifestyle changes such as weight loss and physical activity are advocated for the treatment of these chronic diseases and endpoints, and data are emerging which suggest that these treatments may be beneficial, in part, due to their anti-inflammatory effects. Identification of effective therapies that reduce chronic inflammation for Veterans is important given the widespread adverse health effects of a chronically elevated inflammatory state.

Conditions

Inflammation; Insulin Sensitivity

Keywords

Glucose Metabolism

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.

  Baseline and 6 month

Secondary Outcomes (2)

• Body Weight

  Baseline and 6 month

• Fitness

  Baseline and 6 month

Study Arms (2)

Arm 1

EXPERIMENTAL

6 months of aerobic exercise training

Other: Aerobic Exercise Training

Arm 2

EXPERIMENTAL

6 months of weight loss

Other: Weight Loss

Interventions

Weight Loss OTHER

6 months of weight loss

Arm 2

Aerobic Exercise Training OTHER

6 months of aerobic exercise training

Arm 1

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female
• yrs of age
• Non-smoking for one year
• Body mass index greater than 20 kg/m2 and less than 50 kg/m2
• Menopause over 1 year

You may not qualify if:

• Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension (blood pressure over 180/100 mm Hg) unless medically stabilized
• Currently being treated for active cancer
• Type 1 diabetes; Insulin or oral agent treatment for diabetes, poorly controlled diabetes fasting blood glucose over 160 mg/dl
• Allergic to lidocaine
• Untreated dyslipidemia with National Cholesterol Adult Treatment Panel III 10 year cardiac risk score greater than 10%, or receiving triglyceride lowering meds
• Other systemic disorders that are not medically treated and stable
• Taking beta-blockers, oral steroids, warfarin or any other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (ie for 72 hours prior)
• Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120mm Hg, or other contraindications to exercise) \*requires follow up treatment w/ primary MD for continued participation in study
• Abnormal liver function
• Abnormal renal function
• Chronic pulmonary disease
• Anemia hematocrit below 35 mg/dl, platelets below 100,000/cm3
• Mini-mental state exam below 24, dementia or unstable clinical depression by exam
• Aerobically trained with maximal oxygen consumption greater than 2 standard deviations above age-adjusted mean
• Exercise group only: History of cerebrovascular disease (by medical history) with symptoms limiting the ability to exercise

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Inflammation; Insulin Resistance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Alice Ryan
• Organization: Baltimore VAMC

aryan@grecc.umaryland.edu

410-605-7851

Study Officials

• Alice S Ryan, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 16, 2008
• Study Start: April 1, 2007
• Primary Completion: November 29, 2012
• Study Completion: November 29, 2012
• Last Updated: June 26, 2018
• Results First Posted: December 22, 2014

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)