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

NCT01580813

Last updated date
Study Location
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
Official Title  ICMJE Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01580813
Other Study ID Numbers  ICMJE 10-1393
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • US Department of Veterans Affairs
  • Pfizer
Investigators  ICMJE
Principal Investigator:Irene Schauer, M.D., Ph.D.University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2020

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