Mitochondrial Effects of C18:0 Supplementation in Humans

Type2 Diabetes Clinical Trial

Official title:

Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957838
• Other study ID #: S-675/2015
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: November 23, 2017
• Start date: November 2016
• Est. completion date: November 18, 2017

Study information

• Verified date: November 2017
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 18, 2017
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alteration of Mitochondrial Membrane
• Diabetes Mellitus, Type 2
• Fatty Acid Deficiency
• Type2 Diabetes

Intervention

Dietary Supplement:
• C18:0
Receives 24g of C18:0 in a low-fat banana milkshake.
• mock
Low fat banana milkshake without C18:0 supplement.

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Primary	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.	on the day of supplementation at 0, 3 and 6 h
Secondary	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.	2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Secondary	plasma methylglyoxal levels	Methylglyoxal levels in plasma analyzed via liquid chromatography-mass spectrometry. Changes will be correlated to primary endpoints.	2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Secondary	plasma fatty acid levels	Fatty acids along with other lipid parameters like triglycerides and cholesterol for normalization purposes will be measured.	2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Secondary	insulin resistance	Insulin and glucose levels will be measured at each time point, HOMA index will be calculated.	2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Secondary	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.	2 days before supplementation