Back to resultsInsulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
Primary Purpose
Insulin Resistance, Impaired Fasting Glucose
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Nateglinide
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance focused on measuring Postprandial endothelial function
Eligibility Criteria
Inclusion Criteria: Insulin resistance, impaired glucose tolerance Exclusion Criteria: unstable chronic disease, acute disease
Sites / Locations
- Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital
Outcomes
Primary Outcome Measures
Endothelial function
Secondary Outcome Measures
Metabolic function
Full Information
NCT ID
NCT00259168
First Posted
November 28, 2005
Last Updated
November 29, 2018
Sponsor
Atheline Major-Pedersen
Collaborators
Novartis, Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00259168
Brief Title
Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
Official Title
Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Atheline Major-Pedersen
Collaborators
Novartis, Bayer
4. Oversight
5. Study Description
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.
Detailed Description
Background:Insulin Resistance (IR) is accompanied by a high incidence and prevalence of cardiovascular disease. IR is present in individuals with pre-diabetes/ type 2 diabetes. Epidemiological data demonstrate a tight relationship between postprandial blood sugar, insulin resistance and cardiovascular disease (CVD). Endothelial dysfunction seems to be the very first sign of CVD.
Purpose: We propose to determine whether attenuation /normalization of post-prandial hyperglycaemia, through the administration of an oral hypoglycaemic agent of ultra rapid action (nateglinide), ameliorates endothelial function in the IR.
We extrapolate that a better endothelial function in the brachial artery reflects regression of atherosclerotic changes in the coronary system.
Method and Study Design: Prospective, open, parallel, group comparison study of 1 intervention group, 1 intervention control group and 1 disease control group. The intervention group and the intervention control group each consist of 30 individuals with IR. Individuals in the intervention group receive an individually adjusted dose of nateglinide 3 times daily during 12 weeks. The third group consists of 10 healthy, young individuals. All groups are followed during 3 months with an otherwise unchanged lifestyle. Endothelial function is measured with the Flow Mediated Dilation method before and after the intervention/observation period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Impaired Fasting Glucose
Keywords
Postprandial endothelial function
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nateglinide
Primary Outcome Measure Information:
Title
Endothelial function
Secondary Outcome Measure Information:
Title
Metabolic function
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
Insulin resistance, impaired glucose tolerance
Exclusion Criteria:
unstable chronic disease, acute disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Torp-Pedersen, MD, DMSc
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital
City
Bispebjerg Bakke, Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
12208795
Citation
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.
Results Reference
background
PubMed Identifier
1359209
Citation
Celermajer 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.
Results Reference
background
PubMed Identifier
11788217
Citation
Corretti 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. Erratum In: J Am Coll Cardiol 2002 Mar 20;39(6):1082.
Results Reference
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Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
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