NCT00277342

Brief Summary

The investigators hypothesise that a common A277G polymorphism of the liver fatty acid binding protein (L-FABP) gene, which leads to an amino acid exchange, may be associated with alterations of lipid-induced hepatic insulin resistance. In the present study the investigators will investigate potential differences in lipid-induced hepatic insulin resistance, and in the relation between glycogenolysis and gluconeogenesis, in healthy subjects with the A277G polymorphism vs. subjects carrying the wildtype.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

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

January 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 4, 2012

Status Verified

August 1, 2006

First QC Date

January 12, 2006

Last Update Submit

May 3, 2012

Conditions

WildtypePolymorphism Liver FABP

Keywords

lipid induced hepatic insulin resistancepolymorphisms liver fatty-acid-binding-proteingluconeogenesisglycogenolysisendogenous glucose production

Outcome Measures

Primary Outcomes (2)

  • lipid-induced hepatic insulin resistance(WT vs.SNP L-FABP)

  • changes in the relation GNG to GL

Secondary Outcomes (1)

  • changes in peripheral plasma glucose and lipid responses

Interventions

measurement of lipid-induced hepatic insulin resistancePROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects with normal glucose tolerance (NGT)

You may not qualify if:

  • any severe cardiac, liver, or kidney diseases
  • pregnant or lactating women, menstrual irregularities
  • cortisone, antidiabetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Institute of Human Nutrition DIfE, Dpt. of Clinical Nutrition, Potsdam-Rehbrücke

Nuthetal, 14558, Germany

Location

Related Publications (1)

  • Weickert MO, Loeffelholz CV, Roden M, Chandramouli V, Brehm A, Nowotny P, Osterhoff MA, Isken F, Spranger J, Landau BR, Pfeiffer AF, Mohlig M. A Thr94Ala mutation in human liver fatty acid-binding protein contributes to reduced hepatic glycogenolysis and blunted elevation of plasma glucose levels in lipid-exposed subjects. Am J Physiol Endocrinol Metab. 2007 Oct;293(4):E1078-84. doi: 10.1152/ajpendo.00337.2007. Epub 2007 Aug 14.

    PMID: 17698986RESULT

Study Officials

  • Martin O Weickert, MD

    German Institute of Human Nutrition; Charité Campus Benjamin Franklin

    PRINCIPAL INVESTIGATOR

  • Matthias Möhlig, MD

    German Institute of Human Nutrition; Charité Campus Benjamin Franklin

    PRINCIPAL INVESTIGATOR

  • Andreas FH Pfeiffer, MD

    German Institute of Human Nutrition; Charité Campus Benjamin Franklin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

January 1, 2006

Study Completion

April 1, 2006

Last Updated

May 4, 2012

Record last verified: 2006-08

Locations

DE(1)