Clinical trials: Mitochondrial Metabolism
Friedreich's Ataxia
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study
The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.
- Trial name
- STEADFAST (NCT02593773)
- Testing
- Interferon γ-1b
- Where
- 4 sites in United States
- Volunteers
- 86 people
- Sponsor
- Amgen
COVID-19
Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)
This current proposal evaluates the Longitudinal Energy Expenditure and Metabolic Effects in Patients with COVID-19 (LEEP-COVID) to understand, guide and optimize our metabolic and nutritional care of these high risk patients.
- Trial name
- NCT04350073
- Testing
- Q-NRG Metobolic Cart Device, MuscleSound Ultrasound, Multifrequency Bioimpedance Spectroscopy
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Duke University
Heart Failure, Ischemia Reperfusion Injury
Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
This proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.
- Conditions
- Heart Failure, Ischemia Reperfusion Injury, Mitochondrial Pathology
- Trial name
- NCT04379934
- Testing
- 3-hydroxybuturate
- Where
- Denmark
- Volunteers
- 40 people
- Sponsor
- University of Aarhus
Mitochondrial Disease
Acute Infection in Mitochondrial Disease: Metabolism, Infection and Immunity
Background: Mitochondrial disease is a rare disorder. It can cause poor growth, developmental delays, muscle weakness, and other symptoms. The disease is usually inherited. It can be present at birth or develop later in life.
- Trial name
- NCT04419870
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- National Human Genome Research Institute (NHGRI)
Friedreich Ataxia
Friedreich Ataxia Nerve Ultrasund
"Friedreich ataxia is the most common inherited autosomal recessive ataxia. It is caused by a GAA repeat expansion in the frataxin gene on chromosome 9q21.11.
- Trial name
- FAUST (NCT07508631)
- Testing
- Nerve ultrasound - routine exam
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Cytomegalovirus Retinitis, HIV Infections
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.
- Trial name
- NCT00000688
- Testing
- Ganciclovir
- Where
- 22 sites in United States
- Volunteers
- 180 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diabetes, Hypothyroidism
Thyroid Study Type 2 Diabetes Mellitus (T2DM)
Background of the study: Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight loss, which could be beneficial for treating obesity, and type 2 diabetes.
- Trial name
- NCT01379170
- Testing
- Euthyrox (levothyroxine)
- Where
- Netherlands
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Statin Adverse Reaction, Statin-induced Myopathy
Metabolic and Mitochondrial Changes in Statin-Induced Myopathy
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins.
- Trial name
- NCT07511686
- Testing
- Blood sampling and laboratory assessment, Muscle biopsy
- Where
- Latvia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Riga Stradins University
Type 2 Diabetes, Oxidative Stress
The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise
Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise.
- Conditions
- Type 2 Diabetes, Oxidative Stress, Mitochondrial Reactive Oxygen Species Production
- Trial name
- DIMITOS (NCT02948673)
- Testing
- Glutathione
- Where
- Denmark
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Parkinson Disease
N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease
N-DOSE is a double-blinded placebo-controlled randomized trial aiming to determine the optimal biological dose (OBD) of nicotinamide riboside (NR), in individuals with Parkinson's disease (PD).
- Trial name
- NCT05589766
- Testing
- Nicotinamide Riboside
- Where
- Norway
- Volunteers
- 81 people
- Sponsor
- Haukeland University Hospital
HIV Infection, Mitochondrial Dysfunction
Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression
The purposes of this study are to evaluate if switching an antiretroviral medication from efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change: 1.
- Trial name
- NCT01194856
- Testing
- Atazanavir/ritonavir, Efavirenz
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- The Cleveland Clinic
Autism Spectrum Disorder
Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder
The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in…
- Trial name
- NCT03835117
- Testing
- Wide-spectrum nutritional supplement
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Rossignol Medical Center
Urea Cycle Disorder, Organic Acidemia
Systemic Biomarkers of Brain Injury From Hyperammonemia
Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and…
- Conditions
- Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I
- Trial name
- NCT04602325
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's National Research Institute
MELAS
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.
- Trial name
- NCT04475549
- Testing
- IW-6463 Tablets
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tisento Therapeutics
Mitochondrial Diseases, Bone Remodeling Disorder
The Impact of Mitochondrial Dysfunction on Human Bone Cell Metabolism and Remodelling
Cell and mice studies suggest mitochondrial dysfunction may cause altered bone structure. Hypothesis: Decreased mitochondrial energy production affects bone cell development and activity negatively.
- Trial name
- NCT05483738
- Testing
- Clinical assessment, blood samples, bone marrow and bone biopsy
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Aalborg University Hospital
Thymidine Kinase 2 Deficiency
A Study of the Efficacy and Safety of MT1621 in Thymidine Kinase 2 (TK2) Deficiency (Treatment naïve)
This is a Phase 3b, prospective, single-arm, multicenter, open-label treatment study of the efficacy and safety of MT1621 in pediatric and adolescent patients with thymidine kinase 2 deficiency (TK2d).
- Trial name
- NCT04581733
- Testing
- MT1621
- Sponsor
- Zogenix MDS, Inc.
Pediatric Obesity, Insulin Resistance
Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity
Obesity and type 2 diabetes are occurring at epidemic rates in the United States and worldwide. The global burden of diabetes is estimated to double over the next 25 years.
- Conditions
- Pediatric Obesity, Insulin Resistance, Mitochondrial Dysfunction
- Trial name
- NCT00962806
- Testing
- Exercise, Lifestyle counseling
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice.
- Conditions
- Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy, Stargardt Disease
- Trial name
- PupDyn (NCT04909398)
- Testing
- Dynamic pupillometry sessions
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Autism Spectrum Disorder, Mitochondrial Pathology
Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting.
- Conditions
- Autism Spectrum Disorder, Mitochondrial Pathology, Epilepsy, Brain Tumor
- Trial name
- NCT04322734
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Southwest Autism Research & Resource Center
Rare Diseases, Mitochondrial Diseases
A Multi-Dimensional Model of cAre and transItion for Patients With cOmplex RAre Diseases
Over the past century, the progress in biomedical sciences gave outstanding contributions to the understanding of human conditions, and even curing some of them.
- Conditions
- Rare Diseases, Mitochondrial Diseases, Muscular Dystrophies, Dysmorphic Disorder, Body
- Trial name
- AD-MAIORA (NCT07558213)
- Testing
- Etiopathogenetic diagnosis, Functional diagnosis
- Where
- Italy
- Volunteers
- 136 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS