Understanding how mitochondrial stress affects obesity resistance
Energy Balance and Mitochondrial Function in Human Genetic Models of Mitochondrial Stress-mediated Obesity Resistance
This study is trying to see how mitochondrial stress affects weight and energy balance in people with mitochondrial DNA mutations compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06080568 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between mitochondrial stress and energy balance in individuals with mitochondrial DNA mutations compared to healthy controls. Participants will undergo assessments of energy expenditure, appetite sensation, and energy intake, along with muscle and adipose tissue biopsies. The study design is a case-control format, involving 15 individuals with mitochondrial mutations and 15 matched healthy controls. The goal is to uncover the cellular mechanisms that may confer protection against obesity in those with mitochondrial disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals with known pathogenic mitochondrial DNA mutations.
Not a fit: Patients with severe heart disease, dysregulated thyroid conditions, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into new strategies for preventing obesity in individuals with mitochondrial dysfunction.
How similar studies have performed: While there is emerging evidence from pre-clinical models, this specific approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility criteria for individuals with mitochondrial DNA mutations Inclusion criteria: - Known mtDNA point mutations Exclusion criteria: * Use of antiarrhythmic medications or other medications which, in the opinion of the investigators, have the potential to affect outcome measures. * Diagnosed severe heart disease, dysregulated thyroid gland conditions, or other dysregulated endocrinopathies, or other conditions which, in the opinion of the investigators, have the potential to affect outcome measures. * Pregnancy Eligibility criteria for controls Exclusion criteria: * Current and regular use of antidiabetic medications or other medications which, in the opinion of the investigators, have the potential to affect outcome measures. * Diagnosed heart disease, symptomatic asthma, liver cirrhosis or -failure, chronic kidney disease, dysregulated thyroid gland conditions or other dysregulated endocrinopathies, or other conditions which, in the opinion of the investigators, have the potential to affect outcome measures * Daily use of tobacco products * Excessive alcohol consumption * Pregnancy
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Matteo Fiorenza, Ph.D. — Rigshospitalet, Denmark
- Study coordinator: Matteo Fiorenza, Ph.D.
- Email: matteo.fiorenza@regionh.dk
- Phone: +4535458748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.