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NCT04698486
Hepatic and Cardiac Metabolic Flexibility in Subjects With T2DM With and Without NAFLD
NA trial testing Hyperinsulinemic euglycaemic clamp in NAFLD - Non-Alcoholic Fatty Liver Disease in 17 participants. Completed in 1 December 2021.
1 December 2021
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 17 |
| Start date | 3 July 2020 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Hyperinsulinemic euglycaemic clamp
Conditions studied
- NAFLD - Non-Alcoholic Fatty Liver Disease — all drugs for NAFLD - Non-Alcoholic Fatty Liver Disease →
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
University of Aarhus
Who can join
Adults 30 to 70, any sex, with NAFLD - Non-Alcoholic Fatty Liver Disease or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from simple reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. Accumulating evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiac steatosis. The mechanisms behind why some subjects progress from NAFLD to NASH and the link between cardiac involvement and NAFLD are poorly understood, but must include altered cardiac and intrahepatic lipid handling. Investigators plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with type 2 diabetes with and without NAFLD and NASH and the relationship with heart function. In addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in type 2 diabetic subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. Investigators will address these questions using tracer techniques (11Cpalmitate PET tracers and triglyceride (TG) tracers) to study cardiac and liver substrate trafficking, as well as MR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04698486
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Currently open trials in the same condition.
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Other University of Aarhus trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04698486 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 27 May 2022
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/NCT04698486.
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