NCT01736202

Brief Summary

The development of type 2 diabetes is based on a combination of insulin resistance and beta cell dysfunction. In the last years, elevated FFA were recognized as a key players in the pathogenesis of insulin resistance and type 2 diabetes. The study compares the acute effects of an oral lipid bolus on insulin sensitivity and hepatic glucose metabolism in healthy humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_4

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, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 25, 2023

Status Verified

June 1, 2023

Enrollment Period

9.8 years

First QC Date

November 26, 2012

Last Update Submit

August 23, 2023

Conditions

Insulin Sensitivity

Keywords

oral fatinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Change in rate of glucose disappearance (Rd)

    Measurement of whole body insulin sensitivity in a hyperinsulinamic euglicamic clamp with deuterated glucose kinetics

    6 hours

Secondary Outcomes (1)

  • Change in rate of hepatic endogenous glucose production (EGP)

    6 hours

Study Arms (3)

Palm oil orally

ACTIVE COMPARATOR

oral fat load

Biological: fat orally

Canola oil orally

ACTIVE COMPARATOR

Oral fat load

Biological: fat orally

Water orally

PLACEBO COMPARATOR

oral water administration as control

Biological: fat orally

Interventions

fat orallyBIOLOGICAL

Oral ingestion of palm oil or canola oil or water at timepoint zero

Also known as: water orally
Canola oil orallyPalm oil orallyWater orally

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male and female subjects
  • age 20-40
  • BMI 20-25 kg/m2

You may not qualify if:

  • hyperlipidemia
  • smoking
  • pregnancy
  • allergy against paracetamol/palm oil/canola oil
  • contraindication for MRI investigations
  • anaemia
  • taking drugs influencing lipid or glucose metabolism, the immune system or antihypertensive treatment
  • M. Meulengracht
  • Hepatitis/HIV
  • chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (3)

  • Sarabhai T, Koliaki C, Mastrototaro L, Kahl S, Pesta D, Apostolopoulou M, Wolkersdorfer M, Bonner AC, Bobrov P, Markgraf DF, Herder C, Roden M. Dietary palmitate and oleate differently modulate insulin sensitivity in human skeletal muscle. Diabetologia. 2022 Feb;65(2):301-314. doi: 10.1007/s00125-021-05596-z. Epub 2021 Oct 26.

    PMID: 34704121DERIVED

  • Sarabhai T, Kahl S, Szendroedi J, Markgraf DF, Zaharia OP, Barosa C, Herder C, Wickrath F, Bobrov P, Hwang JH, Jones JG, Roden M. Monounsaturated fat rapidly induces hepatic gluconeogenesis and whole-body insulin resistance. JCI Insight. 2020 May 21;5(10):e134520. doi: 10.1172/jci.insight.134520.

    PMID: 32434996DERIVED

  • Hernandez EA, Kahl S, Seelig A, Begovatz P, Irmler M, Kupriyanova Y, Nowotny B, Nowotny P, Herder C, Barosa C, Carvalho F, Rozman J, Neschen S, Jones JG, Beckers J, de Angelis MH, Roden M. Acute dietary fat intake initiates alterations in energy metabolism and insulin resistance. J Clin Invest. 2017 Feb 1;127(2):695-708. doi: 10.1172/JCI89444. Epub 2017 Jan 23.

    PMID: 28112681DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michael Roden, Prof., MD

    German Diabetes Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 29, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

August 25, 2023

Record last verified: 2023-06

Locations

DE(1)