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Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes (AcT2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Colorado, Denver
Sponsor:
Collaborators:
VA Office of Research and Development
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01580813
First received: May 24, 2011
Last updated: October 19, 2016
Last verified: October 2016

May 24, 2011
October 19, 2016
June 2011
April 2017   (final data collection date for primary outcome measure)
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve insulin sensitivity, inflammation, and endothelial and cardiac function
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Test the hypothesis that lowering of endogenous NEFA in diabetic adults will improve insulin sensitivity, inflammation, and endothelial and cardiac function
Complete list of historical versions of study NCT01580813 on ClinicalTrials.gov Archive Site
Evaluate the Impact of Acipimox on Exercise Parameters in People with Type 2 Diabetes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output, and peak exercise cardiac function
Same as current
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Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
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.
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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Acipimox
    Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
    Other Name: Olbetam
  • Drug: Placebo
    Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
  • Experimental: Acipimox
    Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi
    Intervention: Drug: Acipimox
  • Placebo Comparator: Placebo
    Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2018
April 2017   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years   (Adult)
No
Contact: Katie M Rogers, M.S. 720-848-6688 katie.rogers@ucdenver.edu
Contact: Ian Leavitt, M.S. 720-848-7103
United States
 
NCT01580813
10-1393
Yes
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
  • VA Office of Research and Development
  • Pfizer
Principal Investigator: Irene Schauer, M.D., Ph.D. University of Colorado, Denver
University of Colorado, Denver
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP