MItochondrial Diabetes LOw Carb- Diet Study

NCT06185790 | Completed DMC

• 1 other identifier: NL85039.091.23
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mitochondrial Diseases; Diabetes-Deafness Syndrome Maternally Transmitted

Keywords

low carbohydrate high fat diet; gut microbiome; mitochondrial diabetes

Outcome Measures

Primary Outcomes (2)

• Goal Attainment Scaling (GAS)

  The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. The scores can range from -2 to +2 with 1-point increments. A score of 0 indicates that the expected level is reached. A negative score means that the level reached was lower than expected, and can be classified as lower (-1) of much lower (-2). A positive score means that the level reached was higher than expected, and can be classified as higher (+1) of much higher (+2).

  12 weeks

• Faecal microbiome composition analyses via DNA isolation

  The faecal microbiome composition of the participants with their usual diet will be compared the faecal microbiome composition after adhering to the low-carbohydrate high-fat diet. More specifically, DNA will be isolated from the stool samples, and will be compared between the intervention period and the control period.

  12 weeks

Secondary Outcomes (17)

• Glucose monitoring

  12 weeks (home glucose monitoring for two time periods of 10 days)

• Gastrointestinal complaints questionnaire

  12 weeks

• Diet adherence

  3 days

• Checklist Individual Strength (CIS)

  12 weeks

• Newcastle Mitochondrial Disease Adult Scale (NMDAS)

  12 weeks

Study Arms (2)

LCHF diet

EXPERIMENTAL

Participants will adhere to a low-carb high-fat diet for 12 weeks,defined by a carbohydrate intake of 50-100 grams per day.

Other: LCHF diet

Control

NO INTERVENTION

Participants will follow their usual diet for 12 weeks.

Interventions

LCHF diet OTHER

Low-carb high-fat (LCHF) diet

LCHF diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Kidney failure (MDRD \<60 or proteinuria)
• Use of SGLT2-inhibitors
• Already on a carbohydrate restricted diet at baseline (carbohydrate intake \<100 grams per day)
• Pregnancy

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Stichting Stofwisselkracht: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Mitochondrial Diseases; Noninsulin-dependent diabetes mellitus with deafness

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Heidi Zweers- van Essen, Doctor

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 29, 2023
• Study Start: January 5, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)