NCT01229059

Brief Summary

This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

9.7 years

First QC Date

March 20, 2010

Last Update Submit

August 11, 2023

Conditions

Insulin Resistance

Keywords

FFAinsulin resistancemitochondria

Outcome Measures

Primary Outcomes (2)

  • intramyocellular lipid metabolites

    Muscle biopsies are taken before, after 2.5 and 4 hours of lipid infusion

    after 4 hours lipid infusion

  • muscle glucose flux

    glycogen synthesis rate, glucose-6-phosphate

    during lipid infusion

Secondary Outcomes (1)

  • insulin resistance of glucose uptake and mitochondrial function

    after 4 hours lipid infusion

Study Arms (2)

lipid infusion in untrained humans

healthy lean humans before and after lipid infusion

Dietary Supplement: Lipovenös lipid infusion

lipid infusion in athletes

endurance trained atheletes

Dietary Supplement: Lipovenös lipid infusion

Interventions

Lipovenös lipid infusionDIETARY_SUPPLEMENT

Lipid enriched infusions will be applied for 2-6 hours.

Also known as: soy oil
lipid infusion in athleteslipid infusion in untrained humans

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy, lean non-diabetic humans

You may qualify if:

  • non-diabetic (OGTT), no family history of diabetes, BMI\<30 kg/m2, age: 20-55 years, no medication
  • For the athletes group additionally:
  • VO2max \> 60ml/kg/min for males and VO2max \> 45ml/kg/min for females Active in endurance-exercise activities, 3 times a week for at least 2 years Stable level of training for at least 3 months

You may not qualify if:

  • acute illness within the last 2 weeks, autoimmune diseases, renal insufficiency (creatinine\> 1.5 mg/dl), cardiovascular diseases, anemia (Hb\< 12g/l), donation of blood within the last 4 weeks before the study, thyroid diseases, pregnancy, smoking, night-shift working (disturbed circadian rhythm), defective coagulation or wound healing, cancer, allergy against soja products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (2)

  • Phielix E, Begovatz P, Gancheva S, Bierwagen A, Kornips E, Schaart G, Hesselink MKC, Schrauwen P, Roden M. Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion. JCI Insight. 2019 Nov 1;4(21):e127928. doi: 10.1172/jci.insight.127928.

    PMID: 31672941DERIVED

  • Fritsch M, Koliaki C, Livingstone R, Phielix E, Bierwagen A, Meisinger M, Jelenik T, Strassburger K, Zimmermann S, Brockmann K, Wolff C, Hwang JH, Szendroedi J, Roden M. Time course of postprandial hepatic phosphorus metabolites in lean, obese, and type 2 diabetes patients. Am J Clin Nutr. 2015 Nov;102(5):1051-8. doi: 10.3945/ajcn.115.107599. Epub 2015 Sep 30.

    PMID: 26423389DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

muscle biopsies

MeSH Terms

Conditions

Insulin Resistance

Interventions

Soybean Oil

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Michael Roden, Prof., MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2010

First Posted

October 27, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations

DE(1)