Trial of Oral Glutamine on Mitochondrial Function in CKD
Condition: Cardiovascular Disease; Sarcopenia; Endothelial Dysfunction; Muscle Mitochondrial Function; Kidney Disease
MeSH terms: Sarcopenia; Kidney Diseases; Cardiovascular Diseases
Intervention: First Intervention (14 days); Washout (3 weeks); Second Intervention (14 days)
Intervention description: Oral Glutamine or Maltodextrin for 2 weeks; No study product is taken prior to beginning crossover; Oral Glutamine or Maltodextrin for 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 20 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Glutamine; Chronic Kidney Disease

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