Lipodystrophy, Familial PartialFPLNCT02858830
Familial Partial Lipodystrophy Study
A study testing High fat mixed meal in people with Lipodystrophy, Familial Partial, run by Mayo Clinic at 1 site in United States.
Trial summary
Studying patients with rare adipose tissue disorders may help the investigators to better understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and thus have an enormous impact on public health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophy, Familial Partial
- What is being tested?
- High fat mixed meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 14 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of lipodystrophy (decreased subcutaneous fat)
- Family history of lipodystrophy
- Normal control subject
Who cannot join
- Inability to provide informed consent
- Hemoglobin < 10g%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic and Metabolic Basis of Familial Partial Lipodystrophy
Studying patients with rare adipose tissue disorders may help the investigators to better understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and thus have an enormous impact on public health.
Read the detailed description
A systematic study of body fat distribution is necessary to better define the phenotypic spectrum of FPL, and to better recognize FPL in patients with Metabolic Syndrome. Similarly, genetic studies in these patients will not only help better characterize the genotype-phenotype relationship, but is also likely to help identify other genes involved in regulation of lipid homeostasis, as some patients may not have any of the known mutations.
The Investigators will systematically study mitochondrial protein quality and function under fasting and fed state in relation to intramyocellular and circulating plasma lipid levels, and compare with age, sex and BMI-matched individuals. The Investigators will also study the rate of de-novo protein synthesis to determine if hyperinsulinemia affects both muscle protein anabolism and catabolism.
- Conditions
- Lipodystrophy, Familial Partial
- Being tested
- High fat mixed meal
- Keywords
- FPL, adipose tissue, diabetes, dyslipidemia, metabolic, hyperinsulinemia
- Medical subject headings
- Lipodystrophy, Familial Partial, Diabetes Mellitus, Dyslipidemias, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat mixed mealOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Healthy Subject | Other | Healthy Subject (Control) will undergo assessments before and after ingesting a high fat mixed meal. Receives: Other: High fat mixed meal |
| Group 2: FPL Subject | Other | FPL Subject will undergo assessments before and after ingesting a high fat mixed meal. Receives: Other: High fat mixed meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper body muscle strength measured by chest press dynamometry
Measured: Before consumption of a high fat mixed meal
Change in fractional mitochondrial protein synthesis rates
Measured: Before and after consumption of a high fat mixed meal (approximately 4 hours after the meal)
Lower body muscle strength measured by knee extension
Measured: Before consumption of a high fat mixed meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipodystrophy, Familial PartialStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinaya Simha, M.B.B.S., M.D., Mayo Clinic
- Investigators
- Vinaya Simha, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858830
- Sponsor's protocol ID
- 15-009144
- Acronym
- FPL
- Status last verified
- Nov 2021
- First submitted
- 19 May 2016
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Metabolic Basis of Familial Partial Lipodystrophy
- ClinicalTrials.gov ID
- NCT02858830
- Acronym / sponsor ID
- FPL / 15-009144
- Conditions
- Lipodystrophy, Familial Partial
- Keywords
- FPL, adipose tissue, diabetes, dyslipidemia, metabolic, hyperinsulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying patients with rare adipose tissue disorders may help the investigators to better understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and thus have an enormous impact on public health.
Detailed description
A systematic study of body fat distribution is necessary to better define the phenotypic spectrum of FPL, and to better recognize FPL in patients with Metabolic Syndrome. Similarly, genetic studies in these patients will not only help better characterize the genotype-phenotype relationship, but is also likely to help identify other genes involved in regulation of lipid homeostasis, as some patients may not have any of the known mutations.
The Investigators will systematically study mitochondrial protein quality and function under fasting and fed state in relation to intramyocellular and circulating plasma lipid levels, and compare with age, sex and BMI-matched individuals. The Investigators will also study the rate of de-novo protein synthesis to determine if hyperinsulinemia affects both muscle protein anabolism and catabolism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Healthy Subject | Other | Other: High fat mixed mealHealthy Subject (Control) will undergo assessments before and after ingesting a high fat mixed meal. |
| Group 2: FPL Subject | Other | Other: High fat mixed mealFPL Subject will undergo assessments before and after ingesting a high fat mixed meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of lipodystrophy (decreased subcutaneous fat)
- Family history of lipodystrophy
- Normal control subject
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Hemoglobin < 10g%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat mixed meal | Other | Group 1: Healthy Subject, Group 2: FPL Subject |
Primary outcome
Upper body muscle strength measured by chest press dynamometry
Time frame: Before consumption of a high fat mixed meal
Change in fractional mitochondrial protein synthesis rates
Time frame: Before and after consumption of a high fat mixed meal (approximately 4 hours after the meal)
Lower body muscle strength measured by knee extension
Time frame: Before consumption of a high fat mixed meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinaya Simha, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat mixed meal in people with Lipodystrophy, Familial Partial, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper body muscle strength measured by chest press dynamometry (time frame: Before consumption of a high fat mixed meal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.