Lysosomal Acid Lipase DeficiencyNCT03564002
Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
An observational study of Lysosomal Acid Lipase Deficiency and Obesity, run by University Of Perugia at 1 site in Italy.
Trial summary
The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lysosomal Acid Lipase Deficiency, Obesity, Ketogenic Dieting
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2016to 31 Dec 2022
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: obese patients referred to our Clinic in order to assess and treat obesity
Who may be able to join
- BMI > 40 Kg/m2 or > 35 kg/m2 with comorbidities
Who cannot join
- Type-2 diabetes
- Kidney, heart or liver failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Perugia
Perugia, 06132
Graziana Lupattelli, Prof, +390755784023, graziana.lupattelli@unipg.it
About this study
The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.
A VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 43±13, BMI 22.8±2.6 kg/m²) was also included in the study.
- Conditions
- Lysosomal Acid Lipase Deficiency, Obesity, Ketogenic Dieting, Ketosis
- Medical subject headings
- Wolman Disease, Obesity, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obese subjects | Not described | |
| lean subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
lysosomal acid lipase activity
LAL-activity was dosed with dried blood spot (DBS) technique using the inhibitors Lalistat 2
Measured: change from baseline after 25 days
endothelial function
flow mediated dilation at brachial artery by ultrasonography
Measured: change from baseline after 25 days
visceral fat
ultrasonography
Measured: change from baseline after 25 days
liver steatosis
ultrasonography
Measured: change from baseline after 25 days
lipid assessment
total cholesterol, triglycerides, HDL, LDL
Measured: change from baseline after 25 days
general adiposity assessment
bioimpedentiometry
Measured: change from baseline after 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Oct 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lysosomal Acid Lipase DeficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Anastasia Ricci, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564002
- Sponsor's protocol ID
- 2017-12
- Status last verified
- Mar 2020
- First submitted
- 26 May 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
- ClinicalTrials.gov ID
- NCT03564002
- Acronym / sponsor ID
- 2017-12
- Conditions
- Lysosomal Acid Lipase Deficiency, Obesity, Ketogenic Dieting, Ketosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jun 2018 (actual)
- 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.
The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.
A VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 43±13, BMI 22.8±2.6 kg/m²) was also included in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese subjects | – | – |
| lean subjects | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- obese patients referred to our Clinic in order to assess and treat obesity
Key inclusion criteria (1 listed)
- BMI > 40 Kg/m2 or > 35 kg/m2 with comorbidities
Key exclusion criteria (2 listed)
- Type-2 diabetes
- Kidney, heart or liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lysosomal acid lipase activity
Time frame: change from baseline after 25 days
LAL-activity was dosed with dried blood spot (DBS) technique using the inhibitors Lalistat 2
endothelial function
Time frame: change from baseline after 25 days
flow mediated dilation at brachial artery by ultrasonography
visceral fat
Time frame: change from baseline after 25 days
ultrasonography
liver steatosis
Time frame: change from baseline after 25 days
ultrasonography
lipid assessment
Time frame: change from baseline after 25 days
total cholesterol, triglycerides, HDL, LDL
general adiposity assessment
Time frame: change from baseline after 25 days
bioimpedentiometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
Related trials for Lysosomal Acid Lipase Deficiency
Enrolling by invitationObservational study
ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
Acid Sphingomyelinase Deficiency, Ceroid Lipofuscinosis, Neuronal, 2
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
RecruitingObservational study
Registry of Patients Diagnosed With Lysosomal Storage Diseases
Mucopolysaccharidosis I, Mucopolysaccharidosis II
RecruitingPhase 1
PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders)
MPS I, MPS II
RecruitingObservational study
Lysosomal Acid Lipase (LAL) Deficiency Registry
Lysosomal Acid Lipase Deficiency, Cholesterol Ester Storage Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lysosomal Acid Lipase Deficiency and Obesity, run by University Of Perugia at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graziana Lupattelli, Professor (+390755784023, graziana.lupattelli@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lysosomal acid lipase activity (time frame: change from baseline after 25 days). The study lists 6 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 9 Mar 2020.