NCT03657537 (KETOCOGNITION) is a Phase 1 clinical trial of Ketone infusion in Type2 Diabetes, sponsored by Bispebjerg Hospital.

Who is sponsoring NCT03657537?

NCT03657537 is sponsored by Bispebjerg Hospital.

What drugs are being tested in NCT03657537?

Interventions in NCT03657537: Ketone infusion, Saline infusion.

What condition does NCT03657537 study?

NCT03657537 studies Type2 Diabetes, Ketonemia, Cognitive Change.

Is NCT03657537 still recruiting?

NCT03657537 is currently completed. Last updated 20 February 2019.

Last reviewed 2019-02-20 · How we verify

NCT03657537: KETOCOGNITION

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of Ketone Bodies on Cognition in Type 2 Diabetes

Completed Phase 1 Last updated 20 February 2019

What this trial tests

Phase 1 trial testing Ketone infusion in Type2 Diabetes in 18 participants. Completed in 14 February 2019.

Timeline

17 September 2018

Primary endpoint
14 February 2019

14 February 2019

Quick facts

Lead sponsor	Bispebjerg Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	18
Start date	17 September 2018
Primary completion	14 February 2019
Estimated completion	14 February 2019
Sites	1 location across Denmark

Drugs / interventions tested

Ketone infusion — full drug profile →
Saline infusion — full drug profile →

Conditions studied

Type2 Diabetes — all drugs for Type2 Diabetes →
Ketonemia — all drugs for Ketonemia →
Cognitive Change — all drugs for Cognitive Change →

Sponsor

Bispebjerg Hospital

Who can join

Adults 35 to 70, any sex, with Type2 Diabetes or Ketonemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetes negatively affects cognition and increases the risk of developing overt dementia. Decreased cerebral glucose metabolism may be contributing to this effect, thus providing a glucose substitute using ketone bodies might improve neuronal function. In this study the investigators propose to provide quantitative results on cognitive performance during acute hyperketonemia in patients with type 2 diabetes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

56<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
· 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200

Verify or expand the search:

Other recruiting trials for Type2 Diabetes

Currently open trials in the same condition.

NCT05277558 — Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D) · recruiting
NCT05015283 — Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission · NA · recruiting
NCT05006508 — Prevention With the Health and Lifestyle Tool · NA · active not recruiting
NCT04717050 — Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity · NA · active not recruiting
NCT05220917 — Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study · active not recruiting

Other Bispebjerg Hospital trials

Trials by the same sponsor.

NCT06872060 — The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance. · NA · not yet recruiting
NCT07373587 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy · NA · not yet recruiting
NCT07123558 — Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men · NA · not yet recruiting
NCT07124338 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibili · NA · active not recruiting
NCT07096648 — Alert Burden When Monitoring Patients at Home · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03657537 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bispebjerg Hospital
Last refreshed: 20 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03657537.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing