An interventional study of Single Leg Exercise Training in Type 2 Diabetes, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood flow and muscle oxygen uptake. This study will evaluate \& compare exercise function during single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean controls, 15 people with T2DM, and 15 overweight control subjects).
Differences between the exercise responses in people with T2DM and healthy people will help further identify the disease process of T2DM and direct future research of treatments and interventions.
It is well established that functional exercise capacity and peak oxygen uptake (VO2) are reduced in patients with type 2 diabetes mellitus (T2DM) compared with healthy counterparts. The mechanisms underlying the exercise deficit in T2DM remain largely unknown, but previous work has suggested that reduced exercise blood flow and impaired submaximal VO2 may be contributing factors. Both of these findings are consistent with a peripheral impairment of skeletal muscle oxygen delivery, oxygen utilization, or both. Indeed, dysfunction of skeletal muscle metabolism plays a key role in the pathophysiology of T2DM, and considerable work has described abnormalities of oxidative function in the skeletal muscle of people with T2DM. Given this, it is likely that the causes of exercise intolerance in T2DM may relate to specific defects at the level of the skeletal muscle, particularly given that skeletal muscle blood flow and oxidative capacity are impaired in diabetes. However, to our knowledge, no one has related these peripheral muscle abnormalities to the diminished exercise function in this patient group.
The overarching hypothesis for the proposed research is that both a failure to adequately increase muscle oxygen delivery following the onset of exercise and reduced oxidative function of skeletal muscle contribute to the acute oxygen deficit and diminished exercise tolerance that has been observed in patients with T2DM.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 55 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Supervised single leg, exercise training of the index (dominant) calf muscle 5 days per week for two weeks - alternating weight-bearing single leg calf raises and single leg calf extensions by endurance resistance training (weight machine apparatus).
Other: Single Leg Exercise Training
Following the completion of baseline testing, all 3 subject groups will undergo supervised single leg, exercise training of the index (dominant) calf muscle 5 days per week for two weeks - alternating weight-bearing single leg calf raises and single leg calf extensions by endurance resistance training (weight machine apparatus).
Also known as: Exercise Training
Change in Muscle Oxygen Saturation
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.
Time frame: 4.5 hrs each, pre- and post- Exercise Intervention
| Milestone | Type 2 Diabetes | Overweight Controls |
|---|---|---|
| Started | 30 | 25 |
| Completed | 20 | 20 |
| Not completed | 10 | 5 |
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.
| percentage | Type 2 Diabetes | Overweight Controls |
|---|---|---|
| Pre-intervention | -10.7127 ± 6.07805 | -8.9149 ± 6.68906 |
| Post-intervention | -12.471 ± 11.07039 | -8.7883 ± 7.49904 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Type 2 Diabetes | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Overweight Controls | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Type 2 Diabetes | Overweight Controls |
|---|---|---|
| Elevated blood pressure during exerciseVascular disorders | 1/20 | 0/20 |
| Leg hematomaMusculoskeletal and connective tissue disorders | 1/20 | 0/20 |
| Chest pain during exerciseCardiac disorders | 1/20 | 0/20 |
| Age, Categorical(Participants) | Type 2 Diabetes | Overweight Controls | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 14 | 24 |
| >=65 years | 10 | 6 | 16 |
| Age, Continuous(years) | Type 2 Diabetes | Overweight Controls | Total |
|---|---|---|---|
| Mean | 60 ± 9 | 54 ± 12 | 57 ± 11 |
| Sex: Female, Male(Participants) | Type 2 Diabetes | Overweight Controls | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 10 | 10 | 20 |
| Race (NIH/OMB)(Participants) | Type 2 Diabetes | Overweight Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 4 | 3 | 7 |
| White | 16 | 14 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Type 2 Diabetes | Overweight Controls | Total |
|---|---|---|---|
| United States | 30 | 25 | 0 |
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Plan to share: No
The record gives a start of Jun 2012, a primary completion of May 2018 and a completion of May 2018. It does not say whether these dates are actual or estimated.
Results were first posted in May 2019, 11 months after primary completion.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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