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 January 2013 by University of Colorado, Denver
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01580813
First received: May 24, 2011
Last updated: February 20, 2013
Last verified: January 2013
  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 us 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 Blind (Subject, 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 ] [ 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acipimox 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 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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580813

Contacts
Contact: Leah Herlache, MS 720-848-6688 leah.herlache@ucdenver.edu

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
Pfizer
Investigators
Principal Investigator: Irene Schauer, MD, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01580813     History of Changes
Other Study ID Numbers: 10-1393
Study First Received: May 24, 2011
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

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
Acipimox
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014