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Nutritional Ketosis Marfan

ConditionsMarfan SyndromeAortic Dissection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorWashington University School of Medicine

About this trial

In this pilot clinical trial, the investigators will test whether a carefully supervised ketogenic diet can safely help people with Marfan syndrome who already have a chronic or residual aortic dissection. Fifteen participants will work with a study coordinator and dietitian to learn how to follow the diet and will have regular guidance and check-ins. The participants will measure their blood ketone levels at home with a simple finger-stick device and relay their readings to the research team. Every three months, blood samples will also be collected to confirm the body's level of ketosis.

Participants will continue their usual heart and blood-pressure medicines and regular visits with their doctors. Standard of care computed tomography (CT) scans of the aorta will be performed at the start of the study and then again at 6 and 12 months to see if the aorta changes in size.

The main goal is to see how many patients can avoid needing aortic surgery within one year, compared with what is normally expected from past studies. The investigators will also track how well patients follow the diet, how their aorta changes, and whether inflammation in their blood decreases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults between 18 and 50 years old.

Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document.

Genetically or clinically confirmed Marfan syndrome

Chronic descending thoracic aortic dissection present for at least three months

Disqualifiers

Acute or rapidly enlarging dissection (>0.5 cm increase over the preceding three months)

Prior descending thoracic aortic repair or endograft placement

Advanced renal or hepatic dysfunction

Poorly controlled diabetes requiring insulin

Trial design

Design model

Single group

Treatments tested in this trial

  • Ketogenic diet

    Other intervention

    Participants will continue ketogenic diet for 12 months.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Prospective CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from aortic intervention

Freedom from aortic intervention at 12 months compared with historical controls.

Time frame
12 months

Secondary outcomes

1

Aortic dissection and inflammatory markers

Observation of changes related to aortic dissection and inflammatory markers

Time frame
12 months
2

Number of Participants who Maintained Diet Adherence measured by Ketone Monitor

In order to measure adherence, participants will use a handheld ketone meter (Keto-Mojo) to measure β-hydroxybutyrate levels three times per week via saliva as well as finger-stick blood testing.

Time frame
From day 1 to 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: