Clinical trial NCT01580813: Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
Official title: Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
exercise
cardiovascular
heart
insulin sensitivity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Pfizer
First posted: 2012-04-19
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.


Eligibility criteria: Inclusion Criteria:

* Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
* Subjects must have Type 2 Diabetes
* Subjects must be otherwise healthy
* Ages of 30-60 years
* BMI of 25-39 and stable weight for 3 months prior to the start of the study
* Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
* Total glycosylated hemoglobin levels (HbA1C) ≤9% (fair control) on current therapy.

Exclusion Criteria:

* Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
* Concurrent enrollment in an interventional study.
* Any tobacco use either current or within the last year
* Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
* Autonomic dysfunction (\>20 mm fall in upright BP without a change in heart rate) will be excluded.
* Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (\> 1 mm ST segment depression) on screening exercise test.
* Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
* Presence of systolic blood pressure \>190 at rest or \>250 with exercise or diastolic pressure \>95 at rest or \>105 with exercise
* Proteinuria (urine protein \>200 mg/dl) or a creatinine \> 2 mg/dl, suggestive of severe renal disease
* Proliferative retinopathy
* Insulin, incretin, or glitazone treatment
* Niacin treatment
* History of peptic ulcers
* A history of hereditary angioedema
* C1 esterase deficiency
* Women who are pregnant or breastfeeding
* Use of fibrate drugs

Primary outcomes:
measure: Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics
timeFrame: 7 to 9 days
measure: Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2
timeFrame: 7 to 9 days
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: 7 to 9 days
measure: Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate
timeFrame: 7 to 9 days
measure: Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise
timeFrame: 7 to 9 days
measure: Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation
timeFrame: 7 to 9 days
measure: Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function
timeFrame: 7 to 9 days
measure: Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Cardiac Function
timeFrame: 7 to 9 days
measure: Triglycerides
timeFrame: 7 to 9 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Irene Schauer, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: