Clinical trial NCT01785524: Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
Official title: Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Type II Diabetes Mellitus
Keywords: Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Diabetes
Exercise
Functional Capacity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-02-07
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in claudication onset time \[COT\] and peak walking time \[PWT\] relative to a group with the same exercise training but supplemented with placebo .This study is essentially exploratory in nature and designed to provide us with information to adequately develop power and execute a larger study. We have previously seen benefits from nitrate supplementation on function in PAD.


Eligibility criteria: Inclusion Criteria:

* Peripheral Arterial Disease (ABI of less than 0.9)
* Diagnosed Type II Diabetes
* Intermittent Claudication for 3 or more months

Exclusion Criteria:

* Individuals with known alcohol or drug abuse problems
* Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
* Those classified as American Heart Association Class D
* Gangrene, impending limb loss or osteomyelitis
* Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
* Severe peripheral neuropathy
* Any condition other than PAD that limits walking
* Chest pain during treadmill exercise which appears before the onset of claudication, or \>3mm ST depression during exercise
* Subjects taking nitrates or nitroglycerin products
* Must not be taking protein pump inhibitor medications

Primary outcomes:
measure: Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
timeFrame: Baseline & 16 Weeks
measure: Change in Exercise Capacity - Time to Exhaustion (TTE)
timeFrame: Baseline & 16 Weeks
measure: Change in Exercise Capacity - Claudication Onset Time (COT)
timeFrame: Baseline & 16 Weeks
Secondary outcomes:
measure: Change in Functional Ability
timeFrame: Baseline and 16 Weeks
measure: Change in Angiogenesis
timeFrame: Baseline and 16 weeks
measure: Change In Vascular Function
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Diet & Fitness Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woessner M, VanBruggen MD, Pieper CF, Sloane R, Kraus WE, Gow AJ, Allen JD. Beet the Best? Circ Res. 2018 Aug 31;123(6):654-659. doi: 10.1161/CIRCRESAHA.118.313131.