Mitochondrial DiabetesNCT07748130
CoQ10 Effects on MDM Liver Fat Via FibroTouchI.
A study testing Coenzyme Q10 (drug) and Only undergo baseline assessments without intervention. in people with Mitochondrial Diabetes, run by The 95th Hospital of Putian，Putian, Fujian, China at 1 site in China.
Trial summary
Mitochondrial diabetes mellitus (MDM) is a rare subtype of diabetes caused by mitochondrial dysfunction, often accompanied by hepatic steatosis. Coenzyme Q10 (CoQ10), a key electron carrier and antioxidant, may improve mitochondrial function and lipid metabolism. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Diabetes
- What is being tested?
- Coenzyme Q10 (drug) and Only undergo baseline assessments without intervention.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed as a carrier of the mitochondrial DNA m.3243A>G mutation through genetic testing;
- Meeting the diagnostic criteria for diabetes (WHO 1999 diagnostic criteria);
- Aged between 18 and 70 years;
- Willing to participate and having signed the informed consent form.
- Meeting the diagnostic criteria for type 1 diabetes, with positive islet autoantibodies (GAD, IA-2, ICA, etc.);
- Aged between 18 and 70 years;
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- Willing to participate and having signed the informed consent form.
- No history of diabetes, with fasting blood glucose < 5.6 mmol/L and HbA1c < 5.7%;
- Aged between 18 and 70 years;
- Willing to participate and having signed the informed consent form.
Who cannot join
- Type 1 or type 2 diabetes (not caused by mitochondrial gene mutations);
- Comorbid with viral hepatitis, drug-induced hepatitis, alcoholic liver disease, Wilson's disease, or other specific diseases that can lead to fatty liver;
- Severe cardiac, pulmonary, or renal insufficiency;
- Pregnant or lactating women;
- Having used coenzyme Q10 or other mitochondrial-targeted drugs within the past 3 months;
- Having contraindications to MRI examination;
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- Having experienced infection, surgery, or major trauma within the past 4 weeks.
- Withdrawal/Dropout Criteria:
- The subject withdraws informed consent;
- The occurrence of serious adverse events;
- Loss to follow-up;
- Medication adherence that continued participation in < 80%;
- The researcher believes the study is not in the best interest of the subject. 2. Type 1 Diabetes Control Group
- Same as the exclusion criteria (1) to (7) for the mitochondrial diabetes group. 3. Healthy Adult Control Group
- Same as the exclusion criteria (1) to (7) for the mitochondrial diabetes group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The 95th hospital of Putian
Putian, Fujian, 351100
The Scientific Research and Education Department, +8618760590880, Chenxuebai@126.com
About this study
Official title: The Effect of Coenzyme Q10 on Quantitative Changes in Hepatic Fat in Patients With Mitochondrial Diabetes
Mitochondrial diabetes mellitus (MDM) is a rare subtype of diabetes caused by mitochondrial dysfunction, often accompanied by hepatic steatosis. Coenzyme Q10 (CoQ10), a key electron carrier and antioxidant, may improve mitochondrial function and lipid metabolism. This prospective study aims to evaluate the effect of 12-week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP ) in MDM patients with m.3243A>G mutation. An exploratory case-control design will compare baseline characteristics among MDM patients, type 1 diabetes patients, and healthy controls. This study is the first to explore the link between mitochondrial defects and hepatic fat accumulation specifically in MDM, and to test CoQ10 as a potential therapy, offering new insights for both MDM and MAFLD management.
Read the detailed description
- Research Materials Coenzyme Q10: Utilize Coenzyme Q10 formulations that comply with Good Manufacturing Practice (GMP) standards (e.g., Bio-Quinone or equivalent quality products), with each capsule containing 100 mg of Coenzyme Q10 and excipients such as soybean oil and beeswax. Control Medication: None.
- Treatment Protocols Mitochondrial Diabetes Group: On the basis of maintaining the original hypoglycemic treatment regimen (primarily insulin, avoiding metformin), add Coenzyme Q10 at a dose of 100 mg three times daily (total dose of 300 mg/day) for 12 consecutive weeks.
Type 1 Diabetes Control Group and Healthy Control Group: Only undergo baseline assessments without intervention.
Concomitant Medication Regulations:
Maintain the patient's original hypoglycemic treatment regimen unchanged. Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible).
Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period.
If adjustments to hypoglycemic medications are necessary due to clinical conditions, record the medication name, dosage, and reasons for adjustment in detail.
- Conditions
- Mitochondrial Diabetes
- Being tested
- Coenzyme Q10 (drug), Only undergo baseline assessments without intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 (drug)Drug
This prospective study aims to evaluate the effect of 12 week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP) in MDM patients with m.3243A>G mutation. An exploratory case control design will compare baseline characteristics among MDM patients, type 1 diabetes patients, and healthy controls.
Only undergo baseline assessments without intervention.Other
Only undergo baseline assessments without intervention.
Only undergo baseline assessments without intervention.Other
Only undergo baseline assessments without intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mitochondrial Disease Experimental Group | Experimental | This prospective study aims to evaluate the effect of 12 week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP) in MDM patients with m.3243A>G mutation. Receives: Drug: Coenzyme Q10 (drug) |
| Healthy Control Group | Placebo comparator | Only undergo baseline assessments without intervention. Maintain the patient's original hypoglycemic treatment regimen unchanged.
Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible).
Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period. Receives: Other: Only undergo baseline assessments without intervention. |
| Type 1 Diabetes Mellitus Control Group | Active comparator | Maintain the patient's original hypoglycemic treatment regimen unchanged. Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible).
Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period. Receives: Other: Only undergo baseline assessments without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Fat Quantification
The degree of hepatic fat deposition is assessed using the Controlled Attenuation Parameter (CAP) value measured by FibroTouch ultrasound imaging. The CAP value, expressed in dB/m, indicates the severity of hepatic steatosis, with higher values reflecting more advanced fat accumulation in the live.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
Blood biochemistry indicators
- Liver Function Tests (LFTs) Includes: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin (ALB), Total bilirubin (TBIL), etc.
- Kidney Function Tests Includes: Blood urea nitrogen (BUN), Creatinine (Cr), Estimated glomerular filtration rate (eGFR), etc.
- Lipid Panel Includes (TG), High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C), etc.
- Glucose Metabolism Markers Includes: Fasting blood glucose (FBG), Oral glucose tolerance test (OGTT), Glycated hemoglobin (HbA1c), etc.
- Pancreatic Islet Function Tests Includes: Fasting insulin, C-peptide, Glucose-stimulated insulin secretion test (e.g., after OGTT), etc.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 95th Hospital of Putian，Putian, Fujian, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rongfeng zhu, Study chair, The 95th Hospital of Putian, Fujian , China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748130
- Sponsor's protocol ID
- 2025-js020
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira F, Goncalves Bacelar C, Lisboa-Goncalves P, Paulo N, Quental R, Nunes AT, Silva R, Tavares I. Renal manifestations in adults with mitochondrial disease from the mtDNA m.3243A>G pathogenic variant. Nefrologia (Engl Ed). 2023 Dec;43 Suppl 2:1-7. doi: 10.1016/j.nefroe.2024.01.017.
PubMed 38355238Ardekani A, Tabrizi R, Maleki E, Bagheri Lankarani K, Heydari ST, Moradinazar M, Akbari M. Effects of coenzyme Q10 supplementation on lipid profiles and liver enzymes of nonalcoholic fatty liver disease (NAFLD) patients: A systematic review and meta-analysis of randomized controlled trials. Food Sci Nutr. 2023 Mar 13;11(6):2580-2588. doi: 10.1002/fsn3.3315. eCollection 2023 Jun.
PubMed 37324909Fromenty B, Roden M. Mitochondrial alterations in fatty liver diseases. J Hepatol. 2023 Feb;78(2):415-429. doi: 10.1016/j.jhep.2022.09.020. Epub 2022 Oct 7.
PubMed 36209983Loomba R, Friedman SL, Shulman GI. Mechanisms and disease consequences of nonalcoholic fatty liver disease. Cell. 2021 May 13;184(10):2537-2564. doi: 10.1016/j.cell.2021.04.015.
PubMed 33989548Chen Y, Du X, Kuppa A, Feitosa MF, Bielak LF, O'Connell JR, Musani SK, Guo X, Kahali B, Chen VL, Smith AV, Ryan KA, Eirksdottir G, Allison MA, Bowden DW, Budoff MJ, Carr JJ, Chen YI, Taylor KD, Oliveri A, Correa A, Crudup BF, Kardia SLR, Mosley TH Jr, Norris JM, Terry JG, Rotter JI, Wagenknecht LE, Halligan BD, Young KA, Hokanson JE, Washko GR, Gudnason V, Province MA, Peyser PA, Palmer ND, Speliotes EK. Genome-wide association meta-analysis identifies 17 loci associated with nonalcoholic fatty liver disease. Nat Genet. 2023 Oct;55(10):1640-1650. doi: 10.1038/s41588-023-01497-6. Epub 2023 Sep 14.
PubMed 37709864
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coenzyme Q10 on Quantitative Changes in Hepatic Fat in Patients With Mitochondrial Diabetes
- ClinicalTrials.gov ID
- NCT07748130
- Acronym / sponsor ID
- 2025-js020
- Conditions
- Mitochondrial Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The 95th Hospital of Putian，Putian, Fujian, ChinaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mitochondrial diabetes mellitus (MDM) is a rare subtype of diabetes caused by mitochondrial dysfunction, often accompanied by hepatic steatosis. Coenzyme Q10 (CoQ10), a key electron carrier and antioxidant, may improve mitochondrial function and lipid metabolism. This prospective study aims to evaluate the effect of 12-week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP ) in MDM patients with m.3243A>G mutation. An exploratory case-control design will compare baseline characteristics among MDM patients, type 1 diabetes patients, and healthy controls. This study is the first to explore the link between mitochondrial defects and hepatic fat accumulation specifically in MDM, and to test CoQ10 as a potential therapy, offering new insights for both MDM and MAFLD management.
Detailed description
- Research Materials Coenzyme Q10: Utilize Coenzyme Q10 formulations that comply with Good Manufacturing Practice (GMP) standards (e.g., Bio-Quinone or equivalent quality products), with each capsule containing 100 mg of Coenzyme Q10 and excipients such as soybean oil and beeswax. Control Medication: None.
- Treatment Protocols Mitochondrial Diabetes Group: On the basis of maintaining the original hypoglycemic treatment regimen (primarily insulin, avoiding metformin), add Coenzyme Q10 at a dose of 100 mg three times daily (total dose of 300 mg/day) for 12 consecutive weeks.
Type 1 Diabetes Control Group and Healthy Control Group: Only undergo baseline assessments without intervention.
Concomitant Medication Regulations:
Maintain the patient's original hypoglycemic treatment regimen unchanged. Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible).
Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period.
If adjustments to hypoglycemic medications are necessary due to clinical conditions, record the medication name, dosage, and reasons for adjustment in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mitochondrial Disease Experimental Group | Experimental | Drug: Coenzyme Q10 (drug)This prospective study aims to evaluate the effect of 12 week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP) in MDM patients with m.3243A>G mutation. |
| Healthy Control Group | Placebo comparator | Other: Only undergo baseline assessments without intervention.Only undergo baseline assessments without intervention. Maintain the patient's original hypoglycemic treatment regimen unchanged. Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible). Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period. |
| Type 1 Diabetes Mellitus Control Group | Active comparator | Other: Only undergo baseline assessments without intervention.Maintain the patient's original hypoglycemic treatment regimen unchanged. Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible). Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed as a carrier of the mitochondrial DNA m.3243A>G mutation through genetic testing;
- Meeting the diagnostic criteria for diabetes (WHO 1999 diagnostic criteria);
- Aged between 18 and 70 years;
- Willing to participate and having signed the informed consent form.
- Meeting the diagnostic criteria for type 1 diabetes, with positive islet autoantibodies (GAD, IA-2, ICA, etc.);
Key exclusion criteria (15 listed)
- Type 1 or type 2 diabetes (not caused by mitochondrial gene mutations);
- Comorbid with viral hepatitis, drug-induced hepatitis, alcoholic liver disease, Wilson's disease, or other specific diseases that can lead to fatty liver;
- Severe cardiac, pulmonary, or renal insufficiency;
- Pregnant or lactating women;
- Having used coenzyme Q10 or other mitochondrial-targeted drugs within the past 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10 (drug)This prospective study aims to evaluate the effect of 12 week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP) in MDM patients with m.3243A>G mutation. An exploratory case control design will compare baseline characteristics among MDM patients, type 1 diabetes patients, and healthy controls. | Drug | Mitochondrial Disease Experimental Group |
| Only undergo baseline assessments without intervention.Only undergo baseline assessments without intervention. | Other | Healthy Control Group |
| Only undergo baseline assessments without intervention.Only undergo baseline assessments without intervention. | Other | Type 1 Diabetes Mellitus Control Group |
Primary outcome
Liver Fat Quantification
Time frame: From enrollment to the end of treatment at 12 weeks
The degree of hepatic fat deposition is assessed using the Controlled Attenuation Parameter (CAP) value measured by FibroTouch ultrasound imaging. The CAP value, expressed in dB/m, indicates the severity of hepatic steatosis, with higher values reflecting more advanced fat accumulation in the live.
1 secondary outcome
Blood biochemistry indicators
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 38355238Ferreira F, Goncalves Bacelar C, Lisboa-Goncalves P, Paulo N, Quental R, Nunes AT, Silva R, Tavares I. Renal manifestations in adults with mitochondrial disease from the mtDNA m.3243A>G pathogenic variant. Nefrologia (Engl Ed). 2023 Dec;43 Suppl 2:1-7. doi: 10.1016/j.nefroe.2024.01.017.
- Results publication: PubMed 37324909Ardekani A, Tabrizi R, Maleki E, Bagheri Lankarani K, Heydari ST, Moradinazar M, Akbari M. Effects of coenzyme Q10 supplementation on lipid profiles and liver enzymes of nonalcoholic fatty liver disease (NAFLD) patients: A systematic review and meta-analysis of randomized controlled trials. Food Sci Nutr. 2023 Mar 13;11(6):2580-2588. doi: 10.1002/fsn3.3315. eCollection 2023 Jun.
- Results publication: PubMed 36209983Fromenty B, Roden M. Mitochondrial alterations in fatty liver diseases. J Hepatol. 2023 Feb;78(2):415-429. doi: 10.1016/j.jhep.2022.09.020. Epub 2022 Oct 7.
- Results publication: PubMed 33989548Loomba R, Friedman SL, Shulman GI. Mechanisms and disease consequences of nonalcoholic fatty liver disease. Cell. 2021 May 13;184(10):2537-2564. doi: 10.1016/j.cell.2021.04.015.
- Results publication: PubMed 37709864Chen Y, Du X, Kuppa A, Feitosa MF, Bielak LF, O'Connell JR, Musani SK, Guo X, Kahali B, Chen VL, Smith AV, Ryan KA, Eirksdottir G, Allison MA, Bowden DW, Budoff MJ, Carr JJ, Chen YI, Taylor KD, Oliveri A, Correa A, Crudup BF, Kardia SLR, Mosley TH Jr, Norris JM, Terry JG, Rotter JI, Wagenknecht LE, Halligan BD, Young KA, Hokanson JE, Washko GR, Gudnason V, Province MA, Peyser PA, Palmer ND, Speliotes EK. Genome-wide association meta-analysis identifies 17 loci associated with nonalcoholic fatty liver disease. Nat Genet. 2023 Oct;55(10):1640-1650. doi: 10.1038/s41588-023-01497-6. Epub 2023 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rongfeng zhu study chair
The 95th Hospital of Putian, Fujian , China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 (drug) and Only undergo baseline assessments without intervention. in people with Mitochondrial Diabetes, run by The 95th Hospital of Putian，Putian, Fujian, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Lin (+8615160238247, 564310896@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Fat Quantification (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07748130, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.