Clinical trial NCT02957838: Mitochondrial Effects of C18:0 Supplementation in Humans
Official title: Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alteration of Mitochondrial Membrane
Type2 Diabetes
Fatty Acid Deficiency
Keywords: Transferrin Receptor
Type 2 Diabetes
Stearic Acid (C18:0)
Mitochondrial Morphology
Crossover Study
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2016-11-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes, either dietary treatment or oral medication
* must be able to give consent

Exclusion Criteria:

* insulin treated diabetes mellitus
* severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
* conditions of malnourishment
* severe anemia
* pregnancy
* alcohol abuse

Primary outcomes:
measure: Changes in Mitochondrial Morphology
timeFrame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
measure: Changes in Mitochondrial Function
timeFrame: on the day of supplementation at 0, 3 and 6 h
Secondary outcomes:
measure: plasma iron, transferrin, ferritin, ferroportin and hepcidin levels
timeFrame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
measure: plasma methylglyoxal levels
timeFrame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
measure: plasma fatty acid levels
timeFrame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
measure: insulin resistance
timeFrame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
measure: diabetic late complications
timeFrame: 2 days before supplementation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Peter P Nawroth, MD
role: STUDY_DIRECTOR
References:
citation: 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.