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
- Diseases
- Type 2 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.