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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
  Purpose
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.

Condition Intervention
Type 2 Diabetes Drug: Acipimox Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580813


Contacts
Contact: Ellen J Lyon, M.S. 720-848-6690 ellen.lyon@ucdenver.edu
Contact: Ian Leavitt, M.S. 720-848-7103

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Irene Schauer, MD, PhD         
Sponsors and Collaborators
University of Colorado, Denver
VA Office of Research and Development
Pfizer
Investigators
Principal Investigator: Irene Schauer, M.D., Ph.D. University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01580813     History of Changes
Other Study ID Numbers: 10-1393
First Submitted: May 24, 2011
First Posted: April 19, 2012
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
diabetes
exercise
cardiovascular
heart
insulin sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Acipimox
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents