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

NCT ID: NCT01580813

Last Updated: 2021-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-06-05

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Keywords

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diabetes exercise cardiovascular heart insulin sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Acipimox

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Olbetam

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene Schauer, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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10-1393

Identifier Type: -

Identifier Source: org_study_id