Type 2 DiabetesNCT01793909
Type 2 Diabetes and Exercise Function in Single Leg Exercises
A study testing Single Leg Exercise Training in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Single Leg Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with and without type 2 diabetes
- 30-70 years of age
- Lean and overweight
- Sedentary subjects not participating in a regular exercise program (<one bout of exercise/week)
Who cannot join
- Documented cardiovascular disease
- Uncontrolled hypertension: systolic blood pressure (SBP) > 150, diastolic blood pressure (DBP)> 110
- Obstructive pulmonary disease or asthma
- Peripheral neuropathy
- Subjects taking beta blockers, insulin, or Thiazolidinediones (TZD)
- Current or past smoking within the last 2 years
Show all 10Show fewer
- Anemia
- Control HbA1c > 6, T2DM HbA1c > 10
- Type 1 diabetes
- Any implanted metal in subject's body
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Role of Vascular Function: Oxygen Delivery vs Oxygen Utilization in the Exercise Impairment in Type 2 Diabetes
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Single Leg Exercise Training
- Keywords
- Type 2 Diabetes, Exercise Impairment, Blood Flow, Muscle Oxygen Uptake, Exercise Training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Leg Exercise TrainingOther
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| Single Leg Exercise | Other | 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). Receives: Other: Single Leg Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4.5 hrs each, pre- and post- Exercise Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startJun 2012
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judy Regensteiner, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793909
- Sponsor's protocol ID
- 06-0062
- Other IDs
- 1564, 1UL1TR001082
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2012
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vascular Function: Oxygen Delivery vs Oxygen Utilization in the Exercise Impairment in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01793909
- Acronym / sponsor ID
- 06-0062
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Exercise Impairment, Blood Flow, Muscle Oxygen Uptake, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Leg Exercise | Other | Other: Single Leg Exercise TrainingSupervised 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women with and without type 2 diabetes
- 30-70 years of age
- Lean and overweight
- Sedentary subjects not participating in a regular exercise program (<one bout of exercise/week)
Key exclusion criteria (10 listed)
- Documented cardiovascular disease
- Uncontrolled hypertension: systolic blood pressure (SBP) > 150, diastolic blood pressure (DBP)> 110
- Obstructive pulmonary disease or asthma
- Peripheral neuropathy
- Subjects taking beta blockers, insulin, or Thiazolidinediones (TZD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Leg Exercise TrainingAlso: Exercise TrainingFollowing 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). | Other | Single Leg Exercise |
Primary outcome
Change in Muscle Oxygen Saturation
Time frame: 4.5 hrs each, pre- and post- Exercise Intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Regensteiner, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Leg Exercise Training in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Oxygen Saturation (time frame: 4.5 hrs each, pre- and post- Exercise Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.