N/A Completed N=54 Randomized Double-blind Basic Science

Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes

Type 2 Diabetes

Source: ClinicalTrials.gov NCT02804932 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcomePrimary: Maximal Exercise Capacity (VO2max) — 20.7; 20.0; 27.6; 21.9 mL/kg/min

Summary

The purpose of this study is to use a randomized, double-blind, placebo controlled study design to comprehensively investigate the impact of 8-weeks of dietary nitrate supplementation on skeletal muscle blood flow, mitochondrial function, and exercise capacity in patients with type 2 diabetes (T2D).

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximal Exercise Capacity (VO2max)	20.7; 20.0; 27.6; 21.9; 19.7	—
PRIMARY Change in Skeletal Muscle Perfusion During Exercise	156; 143; 200; 175; 143	—
PRIMARY Change in Skeletal Muscle Mitochondrial Function	64.6; 71.0; 87.5; 75.4; 59.8	—

Eligibility Criteria

For 50 patients with documented Type 2 diabetes

Inclusion Criteria

Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
Age is > or = 40 and 10.0%
body mass index > 42 kg/m2
incident cardiovascular events in the last year (heart attack, stroke)
symptomatic coronary artery disease and/or heart failure
uncontrolled hypertension
hypotension (resting systolic BP or = 40 and 42 kg/m2
incident cardiovascular events in the last year (heart attack, stroke)
symptomatic coronary artery disease and/or heart failure
uncontrolled hypertension
hypotension (resting systolic BP < 90 mmHg)
renal impairment with creatinine clearance (eGFR) of <50 ml/min
smoking or history of smoking within past one year
use of medication which contain nitrates
use of anti-coagulant drugs
use of anti-platelet drugs
participation in research studies in which medications or interventions are given which would potentially alter subject responses in the current study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02804932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.