Lipodystrophy and Fat Metabolism During Exercise (NCT04056000) | Clinical Trial Compass
WithdrawnNot Applicable
Lipodystrophy and Fat Metabolism During Exercise
Stopped: ethical and governance issues not resolved
United Kingdom0Started 2019-09-01
Plain-language summary
Mandibular dysplasia with deafness and progeroid features (MDP) syndrome is a rare genetic metabolic disorder that causes lipodystrophy: the inability of the body to store subcutaneous adipose tissue (fat under the skin). This creates a unique scenario where any ingested fat is diverted to the abdomen and liver, often leading to diabetes.
The investigators have an opportunity to study an individual with MDP who has competed in and won national para-cycling championships and is able to prevent/control his diabetes by regular bicycle training. He has approached us for advice on nutritional strategies to improve his cycling performance, and insight into how he uses fat during exercise.
The investigators also wish to study a moderately-trained cyclist with Familial partial lipodystrophy (FPL). Those with FPL show a different pattern of lipodystrophy than those with MDP, allowing us to further increase the investigator's understanding of fat utilisation in those with lipodystrophy during exercise.
The investigators know how subcutaneous fat is used during exercise, and how duration, nutrition, carbohydrate availability, and exercise intensity can affect this. The investigators aim to investigate these processes during exercise in MDP and FPL. This will potentially provide nutrition and performance advice to the individuals, and insight on fat use in lipodystrophy and diabetes.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.