Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 60 |
| Updated: | 10/14/2018 |
| Start Date: | June 2011 |
| End Date: | December 2018 |
| Contact: | Ellen J Lyon, M.S. |
| Email: | ellen.lyon@ucdenver.edu |
| Phone: | 720-848-6690 |
Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes
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.
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.
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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: Irene Schauer, MD, PhD
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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