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Ketosis clinical trials

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NCT ID: NCT04443426 Active, not recruiting - Heart Failure Clinical Trials

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects

KETO-KINETICS1
Start date: April 25, 2019
Phase: Phase 2
Study type: Interventional

The ketone body 3-hydroxybutyrate (3-OHB) is a naturally occurring energy substrate, and is associated with increased life span and improved health. We have previously shown that intravenous 3-OHB treatment increases myocardial blood flow > 70% in healthy humans and data from our group show that 3-OHB increases cardiac output by 40 % in patients with heart failure. In this study the investigators aim to investigate: 1. If this effect is reproducible with a commercially available oral ketone supplements 2. The safety of commercially available ketone supplements in heart failure patients

NCT ID: NCT04370600 Not yet recruiting - Clinical trials for Chronic Heart Failure

Nutritional Ketosis in Heart Failure

INNKA-HF
Start date: June 2020
Phase: Phase 1
Study type: Interventional

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 cohort in order to establish preliminary data to later conduct a multi-center randomized clinical trial.

NCT ID: NCT04309214 Completed - Epilepsy Clinical Trials

Market Research - Acceptability Study for New MCT Fat Products

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.

NCT ID: NCT04309149 Completed - Epilepsy Clinical Trials

Market Research - Acceptability Study for a Range of MCT Products

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study

NCT ID: NCT04275453 Recruiting - Healthy Clinical Trials

Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging

Start date: January 5, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test different methods of preparation that can be used prior to a test called an FDG PET/CT scan. FDG PET/CT scans are routinely done for evaluation of heart inflammation. Standard preparation for the scan includes a ketogenic (high fat and low carbohydrate) diet for 24 hours and overnight fasting to help suppress the amount of sugar taken up in the heart muscle. However, Investigator still do not know if this preparation is the most effective method. So the Investigator, want to investigate alternative methods for decreasing the amount of sugar uptake seen in the heart during FDG PET/CT scan, thus, investigator will have participants try up to 3 different methods of preparation prior to the FDG PET/CT scans to see which type of preparation works the best.

NCT ID: NCT04234867 Terminated - Type 1 Diabetes Clinical Trials

Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)

Dapa-Stress
Start date: May 18, 2022
Phase: Phase 1
Study type: Interventional

Type 1 Diabetes is characterized by an absolute lack of insulin caused by autoimmune ß-cell destruction. Looking for different therapeutic approaches, beyond the administration of Insulin SGLT-Inhibitors (SGLT=sodium-glucose cotransporter) like Dapagliflozin look like a promising option to avoid hyperglycaemic excursions which are a reason for glycaemic variability by renal excretion of excessive glucose without administration of extra insulin. But also euglycemic DKA has been reported during SGLT2 add-on therapy to insulin in T1D and mechanistic studies have been called for. The role of Dapagliflozin-induced hyperglucagonemia and stress/infection precipitating euglycemic DKA in this situation is unclear. Thus the purpose of this pilot study is to collect clinical data on the development of DKA after insulin-withdrawal with Dapagliflozin compared to placebo and the added effect of a single dose of 4mg/kg i.v. ACTH as mediator of stress. The first objective is to investigate the time to DKA (defined as Bicarbonate <19 mmol/l) after insulin withdrawal during treatment with a stable 5 day single daily dose of 10mg Dapagliflozin in patients with type 1 Diabetes. In addition it should be evaluate the additional effect of stress, modelled by a single injection of ACTH on DKA development during Dapagliflozin Treatment. We also want to know if Dapagliflozin influences glucagon levels during insulin withdrawal and how this is associated with the time course of DKA development.

NCT ID: NCT04219709 Recruiting - Type1diabetes Clinical Trials

Effects of Ketosis on Brain Function in Patients With T1DM

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic [very low carbohydrate] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.

NCT ID: NCT04194450 Completed - Type 2 Diabetes Clinical Trials

Exogenous Ketones in Type 2 Diabetes

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.

NCT ID: NCT04156477 Active, not recruiting - Ketosis Clinical Trials

Markers of Appetite Regulation During Exogenous Ketosis

MARK
Start date: October 24, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.

NCT ID: NCT04130724 Completed - Ketosis Clinical Trials

Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status

Start date: October 16, 2019
Phase:
Study type: Observational

The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.