Clinical trial NCT01793909: Type 2 Diabetes and Exercise Function in Single Leg Exercises
Official title: Role of Vascular Function: Oxygen Delivery vs Oxygen Utilization in the Exercise Impairment in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Exercise Impairment
Blood Flow
Muscle Oxygen Uptake
Exercise Training
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Anemia
* Control HbA1c \> 6, T2DM HbA1c \> 10
* Type 1 diabetes
* Any implanted metal in subject's body

Primary outcomes:
measure: Change in Muscle Oxygen Saturation
timeFrame: 4.5 hrs each, pre- and post- Exercise Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Judy Regensteiner, PhD
role: PRINCIPAL_INVESTIGATOR
References: