Trial Outcomes & Findings for Exercise Training and Glucose Metabolism in Aging (NCT NCT00701051)

NCT ID: NCT00701051

Last Updated: 2015-04-06

Results Overview

Insulin-stimulated glucose uptake

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: baseline
• Results posted on: 2015-04-06

Participant Flow

Participant milestones

Measure	Older Adults	Older Adults - Normal Glucose Tolerance Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
Screening STARTED	90	0	0
Screening COMPLETED	31	0	0
Screening NOT COMPLETED	59	0	0
Exercise Intervention STARTED	0	19	12
Exercise Intervention COMPLETED	0	14	9
Exercise Intervention NOT COMPLETED	0	5	3
Detraining Intervention (Optional) STARTED	0	6	6
Detraining Intervention (Optional) COMPLETED	0	6	6
Detraining Intervention (Optional) NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Older Adults	Older Adults - Normal Glucose Tolerance Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
Screening Failed Screening	40	0	0
Screening Time conflicts	19	0	0
Exercise Intervention time conflict; non-study related illness	0	5	3

Baseline Characteristics

Exercise Training and Glucose Metabolism in Aging

Baseline characteristics by cohort

Measure	Older Adults - Normal Glucose Tolerance n=19 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance n=12 Participants Impaired Glucose Tolerance	Total n=31 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 7 • n=5 Participants	60 years STANDARD_DEVIATION 8 • n=7 Participants	60 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Insulin-stimulated glucose uptake

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=19 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance n=12 Participants Impaired Glucose Tolerance
Baseline Glucose Utilization	0.0062 µmol/kgFFM/pmol insulin/min Standard Error .00008	0.0035 µmol/kgFFM/pmol insulin/min Standard Error 0.0004

PRIMARY outcome

Timeframe: baseline, 24 weeks, 26 weeks

Population: Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.

Insulin-stimulated glucose uptake

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=12 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance
Glucose Utilization (Pre/Post Intervention) Baseline	0.041 µmol/kgFFM/pmol insulin/min Standard Error 0.005	—
Glucose Utilization (Pre/Post Intervention) 24-week	0.052 µmol/kgFFM/pmol insulin/min Standard Error 0.006	—
Glucose Utilization (Pre/Post Intervention) 26-week	0.048 µmol/kgFFM/pmol insulin/min Standard Error 0.005	—

PRIMARY outcome

Timeframe: baseline

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=19 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance n=12 Participants Impaired Glucose Tolerance
Baseline Skeletal Muscle Capillarization	313 capillaries/mm2 Standard Error 13	246 capillaries/mm2 Standard Error 8

PRIMARY outcome

Timeframe: baseline, 24 weeks, 26 weeks

Population: Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=12 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance
Skeletal Muscle Capillarization (Pre/Post Intervention) Baseline	289 capillaries/mm2 Standard Error 12	—
Skeletal Muscle Capillarization (Pre/Post Intervention) 24-week	341 capillaries/mm2 Standard Error 21	—
Skeletal Muscle Capillarization (Pre/Post Intervention) 26-week	361 capillaries/mm2 Standard Error 10	—

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=19 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance n=12 Participants Impaired Glucose Tolerance
Baseline 2-hour Postprandial Glucose	107 mg/dl Standard Error 2	160 mg/dl Standard Error 10

SECONDARY outcome

Timeframe: baseline, 24 weeks, 26 weeks

Population: Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=12 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance
2-hr Post-prandial Plasma Glucose Level Baseline	173 mg/dL Standard Error 8	—
2-hr Post-prandial Plasma Glucose Level 24-week	153 mg/dL Standard Error 16	—
2-hr Post-prandial Plasma Glucose Level 26-week	142 mg/dL Standard Error 19	—

SECONDARY outcome

Timeframe: baseline

maximal oxygen consumption

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=19 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance n=12 Participants Impaired Glucose Tolerance
Baseline Cardiorespiratory Fitness	2.2 L/min Standard Error 0.3	1.7 L/min Standard Error 0.2

SECONDARY outcome

Timeframe: baseline, 24 weeks, 26 weeks

Population: Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.

Maximal oxygen consumption

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=12 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance
Cardiorespiratory Fitness Baseline	1.8 L/Min Standard Error 0.1	—
Cardiorespiratory Fitness 24-week	2.3 L/Min Standard Error 0.5	—
Cardiorespiratory Fitness 26-week	2.2 L/Min Standard Error 0.5	—

SECONDARY outcome

Timeframe: baseline, 24 weeks

Population: Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.

Outcome measures

Measure	Older Adults - Normal Glucose Tolerance n=12 Participants Normal Glucose Tolerance	Older Adults - Impaired Glucose Tolerance Impaired Glucose Tolerance
Body Composition (%Fat) Baseline	35 percentage of fat Standard Error 3	—
Body Composition (%Fat) 24-week	33 percentage of fat Standard Error 3	—

Adverse Events

Older Adults

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Older Adults n=90 participants at risk Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants.
Musculoskeletal and connective tissue disorders Fall	1.1% 1/90 • Number of events 1

Additional Information

Steven J. Prior, PhD

Baltimore VA Medical Center

Phone: 410-605-7000

Email: steven.prior@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place