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NCT03804892
Can Brisk Walking Combined With Ingestion of a Lipid-lowering Drug Improve Fat Metabolism in Muscle?
NA trial testing Body Composition in Pre Diabetes in 12 participants. Status unknown.
1 July 2024
Quick facts
| Lead sponsor | Liverpool John Moores University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 12 |
| Start date | 1 October 2019 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Body Composition
- Maximal aerobic fitness test
- Oral glucose tolerance test — full drug profile →
- Muscle biopsy
- Blood samples — full drug profile →
Conditions studied
- Pre Diabetes — all drugs for Pre Diabetes →
Sponsor
Liverpool John Moores University
Who can join
Adults 25 to 55, any sex, with Pre Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Plasma fatty acids levels
Time frame: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.
Blood samples will be assessed for the amount of fatty acids in the blood. -
Skeletal muscle Diacylglycerol (DAG) levels
Time frame: A change from baseline DAGs to DAGS immediately post and 3 hours post exercise trial.
Muscle biopsies will be assessed for lipid metabolites using liquid chromatography-mass spectrometry. -
Plasma Glycerol levels
Time frame: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.
Blood samples will be assessed for the amount of glycerol in the blood throughout the exercise trial. -
IMTG utilisation during exercise
Time frame: A change in amount of IMTG within the muscle from baseline, to immediately post and 3 hours post the exercise intervention.
Muscle samples will be analysed using confocal immunofluorescence microscopy for the amount of IMTG within the samples.
Sponsor's own description
Briefly, participants will be assessed for their eligibility for the study using an oral glucose tolerance test, which involves drinking a sugary drink followed by a series of small blood samples. If eligible, participants will be asked to take part in a fitness test and then two trials which will involve walking on a treadmill at a steady pace. Before and after the exercise a small piece of muscle will be taken from their thigh under local anaesthesia, as well as several small blood samples. Muscle muscle samples will be assessed for lipid metabolites.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03804892
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Liverpool John Moores University trials
Trials by the same sponsor.
- NCT07454317 — Biofeedback Intervention for Paroxysmal Atrial Fibrillation · NA · not yet recruiting
- NCT07469852 — Effects of Caffeine Ingestion on Morning Cognitive and 4-km Time Trial Performance in Males · Phase 1, PHASE2 · active not recruiting
- NCT07366931 — The Effect of Daily Supplementation With Humiome® Post LB on Gastrointestinal Symptoms in Female Athletes · Phase 1, PHASE2 · not yet recruiting
- NCT07466732 — Effects of Caffeine Ingestion on Morning Cognitive and Muscle Repeated Sprint Performance in Males · EARLY_PHASE1 · enrolling by invitation
- NCT07341243 — Exercising in Hot Conditions: How Does it Effect Blood Glucose in People With T1D · NA · recruiting
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 NCT03804892 (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 Liverpool John Moores University
- Last refreshed: 29 December 2023
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/NCT03804892.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing