Trial Outcomes & Findings for Exercise and Inflammation in the Elderly (NCT NCT00753363)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

119 participants

Primary outcome timeframe

Baseline and 6 month

Results posted on

2018-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 6 months of aerobic exercise training Aerobic Exercise Training: 6 months of aerobic exercise training	Arm 2 6 months of weight loss Weight Loss: 6 months of weight loss
Overall Study STARTED	59	60
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	40	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise and Inflammation in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=59 Participants 6 months of aerobic exercise training Aerobic Exercise Training: 6 months of aerobic exercise training	Arm 2 n=60 Participants 6 months of weight loss Weight Loss: 6 months of weight loss	Total n=119 Participants Total of all reporting groups
Age, Customized Age	62 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Body Mass Index	32.4 kg/m2 STANDARD_DEVIATION 6.0 • n=5 Participants	35.7 kg/m2 STANDARD_DEVIATION 4.4 • n=7 Participants	34.1 kg/m2 STANDARD_DEVIATION 5.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 n=19 Participants 6 months of aerobic exercise training Aerobic Exercise Training: 6 months of aerobic exercise training	Arm 2 n=21 Participants 6 months of weight loss Weight Loss: 6 months of weight loss
Insulin Sensitivity baseline	50.2 μmol/kgFFM/min Standard Error 4.5	40.7 μmol/kgFFM/min Standard Error 6.2
Insulin Sensitivity 6 month	57.5 μmol/kgFFM/min Standard Error 4.9	42.3 μmol/kgFFM/min Standard Error 6.1

SECONDARY outcome

Timeframe: Baseline and 6 month

Outcome measures

Outcome measures
Measure	Arm 1 n=19 Participants 6 months of aerobic exercise training Aerobic Exercise Training: 6 months of aerobic exercise training	Arm 2 n=21 Participants 6 months of weight loss Weight Loss: 6 months of weight loss
Body Weight baseline	93.3 kg Standard Error 3.8	103.0 kg Standard Error 3.9
Body Weight 6 month	93.1 kg Standard Error 4.2	93.7 kg Standard Error 3.5

SECONDARY outcome

Timeframe: Baseline and 6 month

Maximal oxygen consumption (VO2max) on a treadmill

Outcome measures

Outcome measures
Measure	Arm 1 n=19 Participants 6 months of aerobic exercise training Aerobic Exercise Training: 6 months of aerobic exercise training	Arm 2 n=21 Participants 6 months of weight loss Weight Loss: 6 months of weight loss
Fitness Baseline	2.38 L/min Standard Error 0.14	2.34 L/min Standard Error 0.12
Fitness 6 month	2.70 L/min Standard Error 0.15	2.29 L/min Standard Error 0.13

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1 n=59 participants at risk 6 months of aerobic exercise training Aerobic Exercise Training: 6 months of aerobic exercise training	Arm 2 n=60 participants at risk 6 months of weight loss Weight Loss: 6 months of weight loss
Gastrointestinal disorders Dizzy and nausea	0.00% 0/59 • Adverse event data were collected between baseline and 6 months.	1.7% 1/60 • Number of events 1 • Adverse event data were collected between baseline and 6 months.

Additional Information

Dr. Alice Ryan

Baltimore VAMC

Phone: 410-605-7851

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place