NCT02957838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

October 24, 2016

Last Update Submit

November 23, 2017

Conditions

Alteration of Mitochondrial MembraneType2 DiabetesFatty Acid Deficiency

Keywords

Transferrin ReceptorType 2 DiabetesStearic Acid (C18:0)Mitochondrial MorphologyCrossover Study

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • plasma iron, transferrin, ferritin, ferroportin and hepcidin levels

    2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

  • plasma methylglyoxal levels

    2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

  • plasma fatty acid levels

    2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

  • insulin resistance

    2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

  • diabetic late complications

    2 days before supplementation

Study Arms (2)

Non-diabetics

EXPERIMENTAL

Non-diabetic volunteers with HbA1c \< 6.5%. Subjects will be treated with C18:0 supplementation or mock.

Dietary Supplement: C18:0Dietary 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.

Dietary Supplement: C18:0Dietary Supplement: mock

Interventions

C18:0DIETARY_SUPPLEMENT

Receives 24g of C18:0 in a low-fat banana milkshake.

Also known as: stearic acid, stearic acid, Sigma-Aldrich, product number W303518
Non-diabeticsType 2 Diabetics
mockDIETARY_SUPPLEMENT

Low fat banana milkshake without C18:0 supplement.

Non-diabeticsType 2 Diabetics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69123, Germany

Location

Related 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.

    PMID: 26214738BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

stearic acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Peter P Nawroth, MD

    University Hospital Heidelberg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

October 6, 2017

Study Completion

November 18, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

All relevant, collected data will be published.

Locations

DE(1)