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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT04056000 |
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Date of registration:
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23/05/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lipodystrophy and Fat Metabolism During Exercise
FAT |
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Scientific title:
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The Regulation of Fat Metabolism in a Cyclist With Lipodystrophy: a Case Study |
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Date of first enrolment:
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September 1, 2019 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT04056000 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Andrew Davenport, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Exeter |
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Key inclusion & exclusion criteria
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SUBJECT WITH FPL
Inclusion:
• Already known to researchers. Male, 29 years old.
CONTROL SUBJECT 1
Inclusion:
- Highly trained, elite-level cyclist (VO2max > 80 ml/kg/min)
- Registered with, and racing under the jurisdiction of, British Cycling
- ~< 10% of body fat
- Male
- 18 - 35 years old
Exclusion:
- Any diagnosed metabolic impairment, as this may affect normal metabolism.
- Any diagnosed cardiovascular disease or hypertension to avoid any complications
associated with heavy exercise.
- Chronic use of any prescribed or over-the-counter pharmaceuticals.
CONTROL SUBJECT 2
Inclusion:
- Recreationally active, preferably with experience of cycling training.
- Similar (± 5 ml·kg-1·min-1) VO2max¬ to that of the participant with MDP
Exclusion:
- Any diagnosed metabolic impairment, as this may affect normal metabolism.
- Any diagnosed cardiovascular disease or hypertension to avoid any complications
associated with heavy exercise.
- Chronic use of any prescribed or over-the-counter pharmaceuticals.
SUBJECT WITH FPL
Inclusion:
- Recreationally active, preferably with experience of cycling training.
- Similar (± 5 ml·kg-1·min-1) VO2max¬ to that of the participant with MDP
- Diagnosis with FPL
Exclusion:
- Female
- Any diagnosed cardiovascular disease or hypertension to avoid any complications
associated with heavy exercise.
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Lipodystrophy, Familial Partial
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Intervention(s)
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Behavioral: 60-minutes of steady state exercise
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Dietary Supplement: High-carbohdyrate breakfast
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Dietary Supplement: Caffeine
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Primary Outcome(s)
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Substrate utilisation
[Time Frame: Throughout the 60 minute cycle]
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Secondary Outcome(s)
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Plasma lactate concentrations
[Time Frame: Throughout the 60 minute cycle]
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Heart rate
[Time Frame: Throughout the 60 minute cycle]
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Plasma glucose concentrations
[Time Frame: Throughout the 60 minute cycle]
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Plasma NEFA concentrations
[Time Frame: Throughout the 60 minute cycle]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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