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NCT06185790Completed

MItochondrial Diabetes LOw Carb- Diet Study

The Effect of a Low Carbohydrate- High Fat Diet on Clinical Symptoms and Gut Microbiome in m.3243A>G Related Mitochondrial Diabetes

Source: ClinicalTrials.gov · Last updated 13 Jan 2025

Brief summary (registry, in English)

In daily practice, doctors and dietitians in the clinic receive many questions in general from patients with a Mitochondrial Disease (MD), and more specific whether nutritional changes can alleviate their symptoms. Mitochondrial Inherited Diabetes and Deafness (MIDD) is due to a mitochondrial mutation at the m.3243A\>G locus. Nutrition is known to affect disease burden in MIDD. Which diet does this best is unknown. Very low carbohydrate high fat diets improve mitochondrial function in isolated cells and in mice. Whether it does so in people with MIDD is unknown. Therefore, the objective of the study is to explore the effect of a low carbohydrate- high fat diet (LCHF) on clinical symptoms (Goal Attainment Scaling) and gut microbiome in patients with MIDD due to the m.3243A\>G mutation. A total of 20 adult patients with the above mentioned characteristics will be randomized to receive first usual care during three months (control period), followed by LCHF dietary intervention for the next three months (intervention period), or vice versa.

Status (registry)
Completed
Study type
Interventional
Enrollment
17 (actual)
First submitted
30 Nov 2023
Start date
5 Jan 2024
Primary completion date
3 Jan 2025
Lead sponsor
Radboud University Medical Center
NCT number
NCT06185790

What you commit to

  • Study type: Interventional
  • Participants enrolled: 17
  • From 5 Jan 2024 to the primary completion date, 3 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of SGLT2-inhibitors

Other illness

  • Kidney failure (MDRD \<60 or proteinuria)

Other

  • Already on a carbohydrate restricted diet at baseline (carbohydrate intake \<100 grams per day)
  • Pregnancy

Who the study is looking for

  • Mitochondrial disease caused by the m.3243A\>G mutation m.3243A\>G mutation
  • BMI ≥ 18.5 kg/m2
  • Good cognitive health

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Radboudumc
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.