Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control
Abstract Introduction Ketogenic 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 e...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-07-01
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| Series: | Endocrinology, Diabetes & Metabolism |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/edm2.264 |
| _version_ | 1818646585325649920 |
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| author | Adrian Soto‐Mota Nicholas G. Norwitz Rhys Evans Kieran Clarke Thomas M. Barber |
| author_facet | Adrian Soto‐Mota Nicholas G. Norwitz Rhys Evans Kieran Clarke Thomas M. Barber |
| author_sort | Adrian Soto‐Mota |
| collection | DOAJ |
| description | Abstract Introduction Ketogenic 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. Methods Twenty 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. Results The 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, p < .01), HbA1c (61 ± 10 mmol/mol to 55 ± 9 mmol/mol [7.7 ± 0.9% to 7.2 ± 0.9%], p < .01), mean daily glucose (7.8 ± 1.4 mM to 7.4 ± 1.3 mM [140 ± 23 mg/dl to 133 ± 25 mg/dl], p < .01) and time in range (67 ± 11% to 69 ± 10%, p < .01). Conclusions Constant ketone monoester consumption over 1 month was safe, well tolerated, and improved glycaemic control in patients with type 2 diabetes. |
| first_indexed | 2024-12-17T00:48:59Z |
| format | Article |
| id | doaj.art-674625e9d0134c78bda58c3bb671aab4 |
| institution | Directory Open Access Journal |
| issn | 2398-9238 |
| language | English |
| last_indexed | 2024-12-17T00:48:59Z |
| publishDate | 2021-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Endocrinology, Diabetes & Metabolism |
| spelling | doaj.art-674625e9d0134c78bda58c3bb671aab42022-12-21T22:09:48ZengWileyEndocrinology, Diabetes & Metabolism2398-92382021-07-0143n/an/a10.1002/edm2.264Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic controlAdrian Soto‐Mota0Nicholas G. Norwitz1Rhys Evans2Kieran Clarke3Thomas M. Barber4Department of Physiology, Anatomy and Genetics The University of Oxford University of Oxford Oxford UKDepartment of Physiology, Anatomy and Genetics The University of Oxford University of Oxford Oxford UKDepartment of Physiology, Anatomy and Genetics The University of Oxford University of Oxford Oxford UKDepartment of Physiology, Anatomy and Genetics The University of Oxford University of Oxford Oxford UKWarwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism University of Warwick Coventry UKAbstract Introduction Ketogenic 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. Methods Twenty 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. Results The 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, p < .01), HbA1c (61 ± 10 mmol/mol to 55 ± 9 mmol/mol [7.7 ± 0.9% to 7.2 ± 0.9%], p < .01), mean daily glucose (7.8 ± 1.4 mM to 7.4 ± 1.3 mM [140 ± 23 mg/dl to 133 ± 25 mg/dl], p < .01) and time in range (67 ± 11% to 69 ± 10%, p < .01). Conclusions Constant ketone monoester consumption over 1 month was safe, well tolerated, and improved glycaemic control in patients with type 2 diabetes.https://doi.org/10.1002/edm2.264diabetesexogenous ketosisketone esterketosis |
| spellingShingle | Adrian Soto‐Mota Nicholas G. Norwitz Rhys Evans Kieran Clarke Thomas M. Barber Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control Endocrinology, Diabetes & Metabolism diabetes exogenous ketosis ketone ester ketosis |
| title | Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control |
| title_full | Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control |
| title_fullStr | Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control |
| title_full_unstemmed | Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control |
| title_short | Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control |
| title_sort | exogenous ketosis in patients with type 2 diabetes safety tolerability and effect on glycaemic control |
| topic | diabetes exogenous ketosis ketone ester ketosis |
| url | https://doi.org/10.1002/edm2.264 |
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