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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.
Verified November 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580813
First Posted: April 19, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
VA Office of Research and Development
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver
May 24, 2011
April 19, 2012
November 6, 2017
June 2011
April 2018   (Final data collection date for primary outcome measure)
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function [ Time Frame: 2 years ]
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 ]
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 ]
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
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Not Provided

*   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 2018   (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
Sexes Eligible for Study: All
30 Years to 60 Years   (Adult)
No
Contact: Ellen J Lyon, M.S. 720-848-6690 ellen.lyon@ucdenver.edu
Contact: Ian Leavitt, M.S. 720-848-7103
United States
 
 
NCT01580813
10-1393
Yes
Studies a U.S. FDA-regulated Device Product: No
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
November 2017

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