Trial Outcomes & Findings for Type 2 Diabetes and Exercise Function in Single Leg Exercises (NCT NCT01793909)

Last Updated: 2023-07-12

Results Overview

The investigators evaluated the dynamics of muscle deoxygenation (O2 extraction) using near infrared spectroscopy (NIRS) during single leg plantar flexion exercise to identify the predominant mechanisms of oxygen delivery versus oxygen utilization abnormalities in the muscle of T2DM during the transition from rest to exercise. These measurements were gathered continuously for 2-5 minutes of multiple exercise bouts within two visits, one prior to the exercise intervention period and one post exercise intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

4.5 hrs each, pre- and post- Exercise Intervention

Results posted on

2023-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Type 2 Diabetes Individuals with a diagnosis of type 2 diabetes	Overweight Controls Individuals with a BMI 25-30 but otherwise healthy.
Overall Study STARTED	30	25
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Type 2 Diabetes and Exercise Function in Single Leg Exercises

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Type 2 Diabetes n=20 Participants Individuals with a diagnosis of type 2 diabetes	Overweight Controls n=20 Participants Individuals with a BMI 25-30 but otherwise healthy.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 9 • n=5 Participants	54 years STANDARD_DEVIATION 12 • n=7 Participants	57 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	25 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 4.5 hrs each, pre- and post- Exercise Intervention

Outcome measures

Outcome measures
Measure	Type 2 Diabetes n=14 Participants Individuals with a diagnosis of type 2 diabetes	Overweight Controls n=13 Participants Individuals with a BMI 25-30 but otherwise healthy.
Change in Muscle Oxygen Saturation Pre-intervention	-10.7127 percentage Standard Deviation 6.07805	-8.9149 percentage Standard Deviation 6.68906
Change in Muscle Oxygen Saturation Post-intervention	-12.471 percentage Standard Deviation 11.07039	-8.7883 percentage Standard Deviation 7.49904

Adverse Events

Type 2 Diabetes

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Overweight Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Type 2 Diabetes n=20 participants at risk Individuals with a diagnosis of type 2 diabetes	Overweight Controls n=20 participants at risk Individuals with a BMI 25-30 but otherwise healthy.
Vascular disorders Elevated blood pressure during exercise	5.0% 1/20 • Number of events 1 • Adverse event data were collected over the course of study participation, approximately 3-4 months for each participant. Overall adverse event data was collected through the entire study, lasting 8 years.	0.00% 0/20 • Adverse event data were collected over the course of study participation, approximately 3-4 months for each participant. Overall adverse event data was collected through the entire study, lasting 8 years.
Musculoskeletal and connective tissue disorders Leg hematoma	5.0% 1/20 • Number of events 1 • Adverse event data were collected over the course of study participation, approximately 3-4 months for each participant. Overall adverse event data was collected through the entire study, lasting 8 years.	0.00% 0/20 • Adverse event data were collected over the course of study participation, approximately 3-4 months for each participant. Overall adverse event data was collected through the entire study, lasting 8 years.
Cardiac disorders Chest pain during exercise	5.0% 1/20 • Number of events 1 • Adverse event data were collected over the course of study participation, approximately 3-4 months for each participant. Overall adverse event data was collected through the entire study, lasting 8 years.	0.00% 0/20 • Adverse event data were collected over the course of study participation, approximately 3-4 months for each participant. Overall adverse event data was collected through the entire study, lasting 8 years.

Additional Information

Dr. Judy Regensteiner

University of Colorado

Phone: 303-724-2247

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place