Trial reportEndocrinology, diabetes & metabolism2021
Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control.
Trial report in Endocrinology, diabetes & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05584371 (Evaluation of the Safety and Tolerability of Exogenous Ketosis Induced by Free Beta-hydroxybutyrate.), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Safety and Tolerability of Exogenous Ketosis Induced by Free Beta-hydroxybutyrate.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Pooled it
- Effects of Exogenous Ketone Supplementation on Blood Glucose: A Systematic Review and Meta-analysis.Advances in nutrition (Bethesda, Md.) · 2022Pooled it
- Effect of weight-maintaining ketogenic diet on glycemic control and insulin sensitivity in obese T2D subjects.BMJ open diabetes research & care · 2024Trial
- Daily consumption of ketone ester, bis-octanoyl (R)-1,3-butanediol, is safe and tolerable in healthy older adults in a randomized, parallel arm, double-blind, placebo-controlled, pilot study.The journal of nutrition, health & aging · 2024Trial
- Effect of Acute Nutritional Ketosis on Circulating Levels of Growth Differentiation Factor 15: Findings from a Cross-Over Randomised Controlled Trial.Biomolecules · 2024Trial
- Enantiomer-Specific Cardiovascular Effects of the Ketone Body 3-Hydroxybutyrate.Journal of the American Heart Association · 2024Trial
- The multifaceted roles of ketones in physiology.Experimental physiology · 2026Review
- β‑hydroxybutyric acid as a potential therapeutic metabolite for type 2 diabetes mellitus (Review).International journal of molecular medicine · 2026Review
- Therapeutic potential of ketone bodies on exercise intolerance in heart failure: looking beyond the heart.Cardiovascular research · 2025Review
- The multi-omics signatures of telomere length in childhood.BMC genomics · 2025Article
- Ketone ester-enriched diet ameliorates motor and dopamine release deficits in MitoPark mice.The European journal of neuroscience · 2024Article
- A secondary β-hydroxybutyrate metabolic pathway linked to energy balance.bioRxiv : the preprint server for biology · 2024Article
- Article
- Effect of the ketone beta-hydroxybutyrate on markers of inflammation and immune function in adults with type 2 diabetes.Clinical and experimental immunology · 2024Article
- The therapeutic potential of ketones in cardiometabolic disease: impact on heart and skeletal muscle.American journal of physiology. Cell physiology · 2024Review
- Article
- Rationale and protocol for a safety, tolerability and feasibility randomized, parallel group, double-blind, placebo-controlled, pilot study of a novel ketone ester targeting frailty via immunometabolic geroscience mechanisms.medRxiv : the preprint server for health sciences · 2023Article
- Association between Impaired Ketogenesis and Metabolic-Associated Fatty Liver Disease.Biomolecules · 2023Review
- 3-Hydroxybutyrate ameliorates insulin resistance by inhibiting PPARγ Ser273 phosphorylation in type 2 diabetic mice.Signal transduction and targeted therapy · 2023Article
- Exogenous ketone supplementation: an emerging tool for physiologists with potential as a metabolic therapy.Experimental physiology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionKetogenic diets have shown to improve glycaemic control in patients with type 2 diabetes. This study investigated the safety, tolerability, and effects on glycaemic control in patients with type 2 diabetes of an exogenous ketone monoester (KE) capable of inducing fasting-like elevations in serum β-hydroxybutyrate (βHB) without the need for caloric or carbohydrate restriction.
methodsTwenty one participants (14 men and 7 women, aged 45 ± 11 years) with insulin-independent type 2 diabetes, and unchanged hypoglycaemic medication for the previous 6 months, were recruited for this non-randomised interventional study. Participants wore intermittent scanning glucose monitors (IS-GM) for a total of 6 weeks and were given 25 ml of KE 3 times daily for 4 weeks. Serum electrolytes, acid-base status, and βHB concentrations were measured weekly and cardiovascular risk markers were measured before and after the intervention. The primary endpoints were safety and tolerability, with the secondary endpoint being glycaemic control.
resultsThe 21 participants consumed a total of 1,588 drinks (39.7 litres) of KE over the course of the intervention. Adverse reactions were mild and infrequent, including mild nausea, headache, and gastric discomfort following fewer than 0.5% of the drinks. Serum electrolyte concentrations, acid-base status, and renal function remained normal throughout the study. Compared to baseline, exogenous ketosis induced a significant decrease in all glycaemic control markers, including fructosamine (335 ± 60 μmol/L to 290 ± 49 μmol/L,
conclusionsConstant ketone monoester consumption over 1 month was safe, well tolerated, and improved glycaemic control in patients with type 2 diabetes.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.