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

NCT01580813 | Completed Results DMC

• 1 other identifier: 10-1393
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; exercise; cardiovascular; heart; insulin sensitivity

Outcome Measures

Primary Outcomes (2)

• Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics

  Evaluate the impact of these effects of NEFA-lowering VO2 kinetics as measured by tau2, the time required for VO2 to reach 67% of peak during submaximal exercise.

  7 to 9 days

• Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2

  Evaluate the impact of these effects of NEFA-lowering on exercise capacity measured as peak VO2.

  7 to 9 days

Secondary Outcomes (7)

• Insulin Sensitivity

  7 to 9 days

• Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate

  7 to 9 days

• Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise

  7 to 9 days

• Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation

  7 to 9 days

• Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function

  7 to 9 days

Study Arms (2)

Acipimox

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Acipimox DRUG

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.

Also known as: Olbetam

Acipimox

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• US Department of Veterans Affairs: collaborator
• Pfizer: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity; Insulin Resistance

Interventions

acipimox

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Hyperinsulinism

Results Point of Contact

• Title: Irene Schauer, MD
• Organization: University of Colorado Denver

clinicalresearchsupportcenter@ucdenver.edu

3037241111

Study Officials

• Irene Schauer, M.D., Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: April 19, 2012
• Study Start: June 1, 2011
• Primary Completion: June 5, 2015
• Study Completion: June 5, 2015
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)