Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?
1 other identifier
interventional
70
1 country
1
Brief Summary
The purpose of this study is to determine whether attenuation/normalization of elevated blood sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2003
Typical duration for phase_4
1 active site
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
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 28, 2005
CompletedFirst Posted
Study publicly available on registry
November 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedDecember 3, 2018
November 1, 2018
2.8 years
November 28, 2005
November 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial function
Secondary Outcomes (1)
Metabolic function
Interventions
Eligibility Criteria
You may qualify if:
- Insulin resistance, impaired glucose tolerance
You may not qualify if:
- unstable chronic disease, acute disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atheline Major-Pedersenlead
- Novartiscollaborator
- Bayercollaborator
Study Sites (1)
Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital
Bispebjerg Bakke, Copenhagen, Copenhagen NV, 2400, Denmark
Related Publications (3)
Ceriello A, Taboga C, Tonutti L, Quagliaro L, Piconi L, Bais B, Da Ros R, Motz E. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation. 2002 Sep 3;106(10):1211-8. doi: 10.1161/01.cir.0000027569.76671.a8.
PMID: 12208795BACKGROUNDCelermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
PMID: 1359209BACKGROUNDCorretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
PMID: 11788217BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Torp-Pedersen, MD, DMSc
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 28, 2005
First Posted
November 29, 2005
Study Start
June 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
December 3, 2018
Record last verified: 2018-11