Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
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ClinicalTrials.gov Identifier: NCT00259168 |
Recruitment Status :
Completed
First Posted : November 29, 2005
Last Update Posted : December 3, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | November 28, 2005 | |||
First Posted Date ICMJE | November 29, 2005 | |||
Last Update Posted Date | December 3, 2018 | |||
Study Start Date ICMJE | June 2003 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Endothelial function | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Metabolic function | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference? | |||
Official Title ICMJE | Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference? | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: Nateglinide | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
70 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2006 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 25 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Not Provided | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00259168 | |||
Other Study ID Numbers ICMJE | 02-005/03 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Atheline Major-Pedersen, Bispebjerg Hospital | |||
Study Sponsor ICMJE | Atheline Major-Pedersen | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bispebjerg Hospital | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |