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Mitochondrial Effects of C18:0 Supplementation in Humans

23. november 2017 opdateret af: Daniel Pfaff, University Hospital Heidelberg

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Tyskland, 69123
        • University of Heidelberg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Non-diabetics
Non-diabetic volunteers with HbA1c < 6.5%. Subjects will be treated with C18:0 supplementation or mock.
Kosttilskud: C18:0
Receives 24g of C18:0 in a low-fat banana milkshake.
Andre navne:
  • stearic acid
  • stearic acid, Sigma-Aldrich, product number W303518
Kosttilskud: mock
Low fat banana milkshake without C18:0 supplement.
Eksperimentel: Type 2 Diabetics
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.
Kosttilskud: C18:0
Receives 24g of C18:0 in a low-fat banana milkshake.
Andre navne:
  • stearic acid
  • stearic acid, Sigma-Aldrich, product number W303518
Kosttilskud: mock
Low fat banana milkshake without C18:0 supplement.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Mitochondrial Morphology
Tidsramme: 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.
2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Changes in Mitochondrial Function
Tidsramme: 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.
on the day of supplementation at 0, 3 and 6 h

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
plasma iron, transferrin, ferritin, ferroportin and hepcidin levels
Tidsramme: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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
plasma methylglyoxal levels
Tidsramme: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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
plasma fatty acid levels
Tidsramme: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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
insulin resistance
Tidsramme: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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
diabetic late complications
Tidsramme: 2 days before supplementation
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Heidelberg

Samarbejdspartnere

German Cancer Research Center

Efterforskere

  • Studieleder: Peter P Nawroth, MD, University Hospital Heidelberg

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2016

Primær færdiggørelse (Faktiske)

6. oktober 2017

Studieafslutning (Faktiske)

18. november 2017

Datoer for studieregistrering

Først indsendt

24. oktober 2016

Først indsendt, der opfyldte QC-kriterier

3. november 2016

Først opslået (Skøn)

8. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S-675/2015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All relevant, collected data will be published.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med C18:0

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