NCT00753363: IRIS

Exercise and Inflammation in the Elderly

Completed NA Results posted Last updated 26 June 2018

What this trial tests

NA trial testing Weight Loss in Inflammation in 119 participants. Completed in 29 November 2012.

Timeline

1 April 2007

Primary endpoint
29 November 2012

29 November 2012

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	119
Start date	1 April 2007
Primary completion	29 November 2012
Estimated completion	29 November 2012
Sites	1 location across United States

Drugs / interventions tested

• Weight Loss — full drug profile →
• Aerobic Exercise Training

Conditions studied

• Inflammation — all drugs for Inflammation →
• Insulin Sensitivity — all drugs for Insulin Sensitivity →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 45 to 80, any sex, with Inflammation or Insulin Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insulin Sensitivity Primary · Baseline and 6 month

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

Group	Value	95% CI
Arm 1	50.2	± 4.5
Arm 2	40.7	± 6.2

6 month

Group	Value	95% CI
Arm 1	57.5	± 4.9
Arm 2	42.3	± 6.1

Body Weight Secondary · Baseline and 6 month

baseline

Group	Value	95% CI
Arm 1	93.3	± 3.8
Arm 2	103.0	± 3.9

6 month

Group	Value	95% CI
Arm 1	93.1	± 4.2
Arm 2	93.7	± 3.5

Fitness Secondary · Baseline and 6 month

Maximal oxygen consumption (VO2max) on a treadmill

Baseline

Group	Value	95% CI
Arm 1	2.38	± 0.14
Arm 2	2.34	± 0.12

6 month

Group	Value	95% CI
Arm 1	2.70	± 0.15
Arm 2	2.29	± 0.13

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected between baseline and 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1

Serious: 0/59 (0%)

Deaths: —

Arm 2

Serious: 0/60 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Arm 1	Arm 2
Dizzy and nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT00753363 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adipose and Skeletal Muscle Expression of Adiponectin and Liver Receptor Homolog-1 With Weight Loss and Aerobic Exercise.
   Ryan AS, Li G. · · 2022 · cited 6× · PMID 35854979 · DOI 10.1210/jendso/bvac095
2. Sex differences in insulin regulation of skeletal muscle glycogen synthase and changes during weight loss and exercise in adults.
   Ryan AS, Li G, McMillin S, Ortmeyer HK. · · 2024 · cited 2× · PMID 38414363 · DOI 10.1002/oby.23987