Alteration of Mitochondrial MembraneNCT02957838
Mitochondrial Effects of C18:0 Supplementation in Humans
A study testing C18:0 and mock in people with Alteration of Mitochondrial Membrane and Type2 Diabetes, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The purpose of this crossover study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alteration of Mitochondrial Membrane, Type2 Diabetes, Fatty Acid Deficiency
- What is being tested?
- C18:0 and mock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to 18 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- type 2 diabetes, either dietary treatment or oral medication
- must be able to give consent
Who cannot join
- insulin treated diabetes mellitus
- severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
- conditions of malnourishment
- severe anemia
- pregnancy
- alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls
The purpose of this crossover study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells will be scored by immunofluorescence and FACS analysis.
Read the detailed description
The purpose of this study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet to reach baseline levels of C18:0 and will then be fed a milkshake supplemented with 24g of C18:0, which corresponds roughly to the C18:0 content of a fast-food meal. Blood samples will be taken at baseline and several hours after intake. We will look at changes in mitochondrial morphology of neutrophils by immunofluorescence, and score mitochondrial function via FACS analysis. Since this study is designed as a crossover study, participants will also receive a mock milk shake after another 2 days of low-fat vegan diet.
- Being tested
- C18:0, mock
- Keywords
- Transferrin Receptor, Type 2 Diabetes, Stearic Acid (C18:0), Mitochondrial Morphology, Crossover Study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C18:0Dietary supplement
Also called stearic acid, stearic acid, Sigma-Aldrich, product number W303518
Receives 24g of C18:0 in a low-fat banana milkshake.
mockDietary supplement
Low fat banana milkshake without C18:0 supplement.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetics | Experimental | Non-diabetic volunteers with HbA1c < 6.5%. Subjects will be treated with C18:0 supplementation or mock. Receives: Dietary Supplement: C18:0; Dietary Supplement: mock |
| Type 2 Diabetics | Experimental | Type 2 Diabetes according to common definitions, but we exclude insulin-treated Type 2 diabetics because nutritional intervention is more difficult/risky. Subjects will be treated with C18:0 supplementation or mock. Receives: Dietary Supplement: C18:0; Dietary Supplement: mock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mitochondrial Morphology
Mitochondria of neutrophils are stained and scored via immunofluorescence microcsopy, either as "fragmented", "intermediate" or "fused". Statistical calculations will be performed on changes in fragmentation status after treatment.
Measured: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Changes in Mitochondrial Function
Mitochondrial membrane potential and ROS production in neutrophils will be analyzed via FACS. Statistical calculations will be performed on changes in the respective levels after treatment.
Measured: on the day of supplementation at 0, 3 and 6 h
Secondary outcomes (5)
plasma iron, transferrin, ferritin, ferroportin and hepcidin levels
Measurement of iron, transferrin, ferritin, hepcidin and ferroportin from serum at all timepoints via ELISA. Changes in plasma levels will be correlated to primary endpoints.
Measured: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
plasma methylglyoxal levels
Methylglyoxal levels in plasma analyzed via liquid chromatography-mass spectrometry. Changes will be correlated to primary endpoints.
Measured: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
plasma fatty acid levels
Fatty acids along with other lipid parameters like triglycerides and cholesterol for normalization purposes will be measured.
Measured: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
insulin resistance
Insulin and glucose levels will be measured at each time point, HOMA index will be calculated.
Measured: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
diabetic late complications
Patients with confirmed HbA1c > 6,5% will be considered diabetic. Then albumin in urine will be measured and diabetic neuropathy will be assessed clinically via NDS/NSS scoring.
Measured: 2 days before supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion6 Oct 2017
- Study completion18 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alteration of Mitochondrial MembraneStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Principal investigator, Daniel Pfaff, University Hospital Heidelberg
- Investigators
- Peter P Nawroth, MD, Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957838
- Sponsor's protocol ID
- S-675/2015
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2016
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All relevant, collected data will be published.
Publications
Senyilmaz D, Virtue S, Xu X, Tan CY, Griffin JL, Miller AK, Vidal-Puig A, Teleman AA. Regulation of mitochondrial morphology and function by stearoylation of TFR1. Nature. 2015 Sep 3;525(7567):124-8. doi: 10.1038/nature14601. Epub 2015 Jul 27.
PubMed 26214738
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls
- ClinicalTrials.gov ID
- NCT02957838
- Acronym / sponsor ID
- S-675/2015
- Keywords
- Transferrin Receptor, Type 2 Diabetes, Stearic Acid (C18:0), Mitochondrial Morphology, Crossover Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- Nov 2016
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 18 Nov 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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.
The purpose of this crossover study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells will be scored by immunofluorescence and FACS analysis.
Detailed description
The purpose of this study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet to reach baseline levels of C18:0 and will then be fed a milkshake supplemented with 24g of C18:0, which corresponds roughly to the C18:0 content of a fast-food meal. Blood samples will be taken at baseline and several hours after intake. We will look at changes in mitochondrial morphology of neutrophils by immunofluorescence, and score mitochondrial function via FACS analysis. Since this study is designed as a crossover study, participants will also receive a mock milk shake after another 2 days of low-fat vegan diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetics | Experimental | Dietary Supplement: C18:0, Dietary Supplement: mockNon-diabetic volunteers with HbA1c < 6.5%. Subjects will be treated with C18:0 supplementation or mock. |
| Type 2 Diabetics | Experimental | Dietary Supplement: C18:0, Dietary Supplement: mockType 2 Diabetes according to common definitions, but we exclude insulin-treated Type 2 diabetics because nutritional intervention is more difficult/risky. Subjects will be treated with C18:0 supplementation or mock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes, either dietary treatment or oral medication
- must be able to give consent
Key exclusion criteria (6 listed)
- insulin treated diabetes mellitus
- severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
- conditions of malnourishment
- severe anemia
- pregnancy
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 |
|---|---|---|
| C18:0Also: stearic acid, stearic acid, Sigma-Aldrich, product number W303518Receives 24g of C18:0 in a low-fat banana milkshake. | Dietary supplement | Non-diabetics, Type 2 Diabetics |
| mockLow fat banana milkshake without C18:0 supplement. | Dietary supplement | Non-diabetics, Type 2 Diabetics |
Primary outcome
Changes in Mitochondrial Morphology
Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Mitochondria of neutrophils are stained and scored via immunofluorescence microcsopy, either as "fragmented", "intermediate" or "fused". Statistical calculations will be performed on changes in fragmentation status after treatment.
Changes in Mitochondrial Function
Time frame: on the day of supplementation at 0, 3 and 6 h
Mitochondrial membrane potential and ROS production in neutrophils will be analyzed via FACS. Statistical calculations will be performed on changes in the respective levels after treatment.
5 secondary outcomes
plasma iron, transferrin, ferritin, ferroportin and hepcidin levels
Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
plasma methylglyoxal levels
Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
plasma fatty acid levels
Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
insulin resistance
Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
diabetic late complications
Time frame: 2 days before supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Background: PubMed 26214738Senyilmaz D, Virtue S, Xu X, Tan CY, Griffin JL, Miller AK, Vidal-Puig A, Teleman AA. Regulation of mitochondrial morphology and function by stearoylation of TFR1. Nature. 2015 Sep 3;525(7567):124-8. doi: 10.1038/nature14601. Epub 2015 Jul 27.
- Individual participant dataSharing planned: Yes. All relevant, collected data will be published.
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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. This study is not recruiting at the moment.
Peter P Nawroth, MD study director
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C18:0 and mock in people with Alteration of Mitochondrial Membrane and Type2 Diabetes, run by University Hospital Heidelberg at 1 site in Germany.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Nov 2017. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mitochondrial Morphology (time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h). The study lists 2 primary outcomes in all. 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 NCT02957838, which also lists 1 linked publication.
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 27 Nov 2017.