Phase 2 N=11 Randomized Triple-blind Treatment

Trial of Oral Glutamine on Mitochondrial Function in CKD

Cardiovascular Disease · Sarcopenia · Endothelial Dysfunction · Muscle Mitochondrial Function · Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT02838979 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Muscle Mitochondrial Function — 0.88; 0.90 mM ATP/s — p=0.15

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: First Intervention (14 days) (Dietary_supplement); Washout (3 weeks) (Other); Second Intervention (14 days) (Dietary_supplement)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Muscle Mitochondrial Function	0.88; 0.90	0.15
SECONDARY Change in Force-time Integral Area Under the Curve in Active Agent vs. Placebo	58.87; 52.36	0.86
SECONDARY Muscle Fatigue	2.52; 2.41	0.44

Summary

The primary goal of proposed investigation is to study the impact of oral glutamine supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial energetics and vascular function using 31P magnetic resonance spectroscopy and optical spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as well as inflammatory and oxidative stress biomarkers among persons with chronic kidney disease.

Eligibility Criteria

Inclusion Criteria

Adults between 20 and 69 years of age
Diagnosis of moderate-severe CKD, defined in this study as an estimated glomerular filtration rate (eGFR) of ≤60ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation
Ability to understand and provide informed consent to participate in the study

Exclusion Criteria

On chronic dialysis
Expectation to start dialysis within 6 months or dialysis access in place.
Pregnant
Have physical immobility (defined by wheelchair use)
Insulin dependent diabetes
Have implants incompatible with MRI
Exercise limiting cardiopulmonary disease (e.g. angina, severe heart valve disease, severe COPD, coronary ischemia)
Use of anticoagulation (i.e. warfarin)
Baseline systolic blood pressure >160 or diastolic blood pressure >100
Inflammatory conditions (e.g. autoimmune disease, HIV)
Thyroid disease
Dementia or inability to consent
Cirrhosis, active/chronic hepatitis
Use medications interfering with muscle or mitochondrial function, including steroids, anti-psychotic, Coenzyme Q-10, immunosuppresssives, antivirals, and muscle relaxants
Weight >300 lbs
Personal history or family history of deep vein thrombosis, pulmonary embolism
Active malignancy
Patients hospitalized within the past 60 days for any reason.
Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02838979). 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.