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Ketosis clinical trials

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NCT ID: NCT06327737 Completed - Metabolic Acidosis Clinical Trials

Diabetic Ketoacidosis Diagnosis and Management

Start date: December 15, 2020
Phase:
Study type: Observational [Patient Registry]

This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema.

NCT ID: NCT06320522 Recruiting - Ketosis Clinical Trials

Exogenous Ketosis in a Fed and a Fasted State

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state. This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism. As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes. Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal.

NCT ID: NCT06318299 Not yet recruiting - Ketosis Clinical Trials

Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid

KetoBrain
Start date: March 2024
Phase: N/A
Study type: Interventional

It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies. Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier. To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study. Aims: - The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint - The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling - If concentration measurements by point-of-care testing are non-inferior to mass spectrometry - If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels

NCT ID: NCT06251895 Completed - Clinical trials for Diabetic Ketoacidosis

Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus

Start date: August 1, 2021
Phase:
Study type: Observational

Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.

NCT ID: NCT06186245 Enrolling by invitation - Diabetes Mellitus Clinical Trials

Starvation in the Treatment of Diabetic Ketoacidosis

Start date: December 27, 2023
Phase: N/A
Study type: Interventional

Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are common, but serious metabolic disorders are often encountered in intensive care. In the intensive care setting, it is common to withhold food from patients during treatment of DKA. However, there is no evidence or current literature supporting this practice. The following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.

NCT ID: NCT06173973 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Start date: March 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.

NCT ID: NCT06114186 Recruiting - Type 1 Diabetes Clinical Trials

FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis

Start date: January 16, 2024
Phase: Early Phase 1
Study type: Interventional

Diabetic ketoacidosis (DKA) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (T1DM) <50 years old. This suggests the need to develop interventions to reduce DKA events. Innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce DKA. Designating a family member, friend, or caregiver as a Follower was associated with reduction in HbA1C, increased time in range, and improvement in quality of life metrics in people with T1DM. However, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with T1DM (prior prospective studies involved either pregnant women with T1DM or adults ≥60 years of age with T1DM). This study is a randomized controlled trial pilot study to evaluate the effectiveness of an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data to reduce severe hyperglycemia, a modifiable risk factor for DKA, in adults with T1DM at high risk for DKA. The intervention uses real-time glucose data sharing with a Follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with T1DM and their chosen Follower). The study hypothesizes that the FAM intervention will reduce the percentage of time spent with glucose ≥250 mg/dL compared to standard care alone.

NCT ID: NCT06097754 Active, not recruiting - Hypoxia Clinical Trials

Intermittent Exogenous Ketosis (IEK) at High Altitude

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Altitude-related hypoxia decreases human functional capacity, especially during exercise. Even with prolonged acclimatization, the physiological adaptations are insufficient to preserve exercise capacity, especially at higher altitudes completely. Consequently, there has been an ongoing search for various interventions to mitigate the negative effects of hypoxia on human performance and functional capacity. Interestingly, early data in rodents and humans indicate that intermittent exogenous ketosis (IEK) by ketone ester intake improves hypoxic tolerance, i.e.by facilitating muscular and neuronal energy homeostasis and reducing oxidative stress. Furthermore, there is evidence to indicate that hypoxia elevates the contribution of ketone bodies to adenosine-triphosphate (ATP) generation, substituting glucose and becoming a priority fuel for the brain. Nevertheless, it is reasonable to postulate that ketone bodies might also facilitate long-term acclimation to hypoxia by upregulation of both hypoxia-inducible factor-1α and stimulation of erythropoietin production. The present project aims to comprehensively investigate the effects of intermittent exogenous ketosis on physiological, cognitive, and functional responses to acute and sub-acute exposure to altitude/hypoxia during rest, exercise, and sleep in healthy adults. Specifically, we aim to elucidate 1) the effects of acute exogenous ketosis during submaximal and maximal intensity exercise in hypoxia, 2) the effects of exogenous ketosis on sleep architecture and quality in hypoxia, and 3) the effects of exogenous ketosis on hypoxic tolerance and sub-acute high-altitude adaptation. For this purpose, a placebo-controlled clinical trial (CT) in hypobaric hypoxia (real high altitude) corresponding to 3375 m a.s.l. (Rifugio Torino, Courmayeur, Italy) will be performed with healthy individuals to investigate both the functional effects of the tested interventions and elucidate the exact physiological, cellular, and molecular mechanisms involved in acute and chronic adaptation to hypoxia. The generated output will not only provide novel insight into the role of ketone bodies under hypoxic conditions but will also be of applied value for mountaineers and athletes competing at altitude as well as for multiple clinical diseases associated with hypoxia.

NCT ID: NCT06080932 Recruiting - Depression Clinical Trials

Ketogenic Intervention in Depression

KIND
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to examine whether a well-formulated ketogenic diet (KD) can be implemented into a university counseling treatment program for major depression and to test whether such a program has any benefit on mental and metabolic health.

NCT ID: NCT06065657 Recruiting - Alcohol Drinking Clinical Trials

Effect of Nutritional Ketosis on Alcohol Metabolism

KAM
Start date: January 18, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The research study is being conducted in health controls to better understand the effects of ketosis on brain functioning after 3 different, randomly assigned, 3-day dietary interventions and the acute effects of alcohol after consuming about 4-5 alcohol beverages. The labs visits will use magnetic resonance imaging (MRI) scans to study the brain, measuring levels of nicotinamide adenine dinucleotide (NAD), lactate, neurotransmitters glutamate, and Gamma-aminobutyric acid (GABA).