Clinical trials: Ketosis, Metabolic
Type2diabetes, Heart Failure With Reduced Ejection Fraction
Ketones, SGLT2, HFrEF
The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection…
- Trial name
- NCT06229678
- Testing
- Empagliflozin 25 MG Oral Tablet, Acipimox 250 Mg Oral Capsule
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Diabetic Ketoacidosis, Type 1 Diabetes Mellitus
Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
A frequent complication in the management of diabetic ketoacidosis (DKA) in children with type 1 diabetes is rebound hyperglycemia (blood glucose over 180 mg/dL) which increases the risk of re-developing DKA and can lengthen the…
- Trial name
- NCT03107208
- Testing
- Glargine, Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
ADPKD
Short Term Induction of Ketosis in PKD
Recently, it has been shown that ketose-inducing dietary interventions slow disease progression in animal models of polycystic kidney disease (PKD), even when the state of ketosis is only induced for a short period of time.
- Trial name
- RESET-PKD (NCT04472624)
- Testing
- Fasting, Ketogenic diet
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- University of Cologne
Ketosis, Metabolic, Immune Functions
The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation
To conduct a single-arm pilot study to determine how acute ingestion of an exogenous ketone monoester supplement alters the histone lysine β-hydroxybutyrylation and immune function in healthy human monocytes and lymphocytes.
- Conditions
- Ketosis, Metabolic, Immune Functions, Histone Deacetylase (HDAC) Activity
- Trial name
- Acute_Ketone (NCT06590623)
- Testing
- Ketone Monoester (KE)
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Post-exercise Period, Ketosis
Acute Effects of Ketone Monoester Co-ingestion With Dietary Protein on Whole-body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Young Males.
The goal of this trial is to determine if ketone monoester supplementation in conjunction with protein supplementation in the post exercise period can augment whole-body protein metabolism following resistance exercise in young…
- Conditions
- Post-exercise Period, Ketosis, Resistance Exercise, Dietary Protein
- Trial name
- (KET-YOUNG-M) (NCT07884539)
- Testing
- Ketone Monoester + Dietary Protein (KET+PRO), Dietary Protein (PRO), Resistance Exercise
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- McGill University
Lysosomal Acid Lipase Deficiency, Obesity
Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity.
- Conditions
- Lysosomal Acid Lipase Deficiency, Obesity, Ketogenic Dieting, Ketosis
- Trial name
- NCT03564002
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Of Perugia
Obesity, Inflammatory Markers
Time-Restricted Feeding
We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity. We will study the effect of restricting the timing of caloric intake to earlier in the day (TRF) versus later in…
- Conditions
- Obesity, Inflammatory Markers, Glycemic Variation, Time Restricted Feeding
- Trial name
- TRIO (NCT04884659)
- Testing
- Time restricted feeding arm, usual feeding pattern arm
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Epilepsy
Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits
This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution.
- Trial name
- NCT00181090
- Testing
- Modified Atkins diet
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Johns Hopkins University
Chronic Heart Failure
Nutritional Ketosis in Heart Failure
Chronic, ambulatory heart failure patients will be given ketone ester dietary supplementation to determine therapeutic efficacy, metabolic adaptation, pharmacokinetics, associated cognitive changes, and safety within this patient…
- Trial name
- INNKA-HF (NCT04370600)
- Testing
- beta hydroxybutyrate (BHB) ester
- Volunteers
- 16 people
- Sponsor
- Thomas Jefferson University
Diabetes Mellitus, Type 2
Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors
Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic…
- Trial name
- NCT02864914
- Testing
- Empagliflozin, DPP-4 inhibitors
- Where
- United Kingdom
- Volunteers
- 333,580 people
- Sponsor
- Boehringer Ingelheim
Type1diabetes
Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications.
- Trial name
- NCT03710928
- Testing
- very low carbohydrate diet, standard carbohydrate diet
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Boston Children's Hospital
Heart Failure, Ketosis
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects
The ketone body 3-hydroxybutyrate (3-OHB) is a naturally occurring energy substrate, and is associated with increased life span and improved health.
- Conditions
- Heart Failure, Ketosis, Ketonemia
- Trial name
- KETO-KINETICS1 (NCT04443426)
- Testing
- Oral 3-hydroxybutyrate salts, Ketone Monoester
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- University of Aarhus
Heart Failure, Systolic, Ketonemia
Effects of Ketones and Niacin in Heart Failure Patients
Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction.
- Trial name
- KETO-COX (NCT04703361)
- Testing
- Niacin, Na-3-OHB
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- University of Aarhus
Diet, Healthy, Health
Medium Chain Fatty Acids and Ketones
16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil.
- Trial name
- MCFA (NCT06289296)
- Testing
- Fatty acid intake in lean and obese males
- Where
- Denmark
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Diabetes Mellitus Type 2
A Study in Type 2 Diabetes Patients Who Are Taking Moderate Dose Insulin, Looking at the Effects of the Medication Luseogliflozin on Risk of Ketoacidosis and Insulin Resistance.
The goal of this clinical trial is to learn if the drug Luseogliflozin works to treat people with diabetes who are taking moderate dose insulin treatment. It will also learn about the safety of the drug Luseogliflozin.
- Trial name
- LUSIRES (NCT07876258)
- Testing
- Luseogliflozin
- Where
- Malaysia
- Volunteers
- 40 people
- Sponsor
- Aimi Fadilah Mohamad
Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction
Chronic Exogenous Ketosis in HFpEF
The goal of this clinical research study is to test what effects a ketone drink will have in people with heart failure with preserved ejection fraction (HFpEF), including on exercise and heart function.
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction, Heart Failure, Diastolic
- Trial name
- NCT06937320
- Testing
- Exogenous Ketone Drink
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Duke University
Lipedema
Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
Lipedema is a female progressive fat disorder, characterized by a symmetrical increase in subcutaneous adipose tissue in the lower extremities with the exception of the waist.
- Trial name
- Lipodiet (NCT04632810)
- Testing
- Ketogenic low energy diet, non-ketogenic low energy diet
- Where
- 2 sites in Norway
- Volunteers
- 70 people
- Sponsor
- Helse Nord-Trøndelag HF
Schizophrenia, Schizophrenia and Related Disorders
Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive…
- Conditions
- Schizophrenia, Schizophrenia and Related Disorders, Bipolar Disorder, Bipolar and Related Disorders
- Trial name
- NCT06748950
- Testing
- LCHF Ketogenic Diet, Diet-as-Usual (DAU)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Stanford University
Exercise, Healthy Male/Female Subjects
Ketone Administration During Inactivity and Retraining
The aim of this study is to investigate the effect of oral ketone administration during inactivity-induced muscle atrophy and retraining-induced regeneration.
- Trial name
- NCT05398042
- Testing
- Ketone ester, Medium Chain Triglyceride (MCT) oil
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Diabetic Ketoacidosis, Insulin
Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients
This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin…
- Conditions
- Diabetic Ketoacidosis, Insulin, Intensive Care Unit Stay
- Trial name
- NCT07423559
- Testing
- insulin infusion without basal insulin, insulin infusion with basal insulin, Insulin infusion with basal insulin and bolus
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Tanta University