Trials / Completed
CompletedNCT00259168
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?
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Atheline Major-Pedersen · Academic / Other
- Sex
- All
- Age
- 25 Years – 75 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nateglinide |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2005-11-29
- Last updated
- 2018-12-03
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00259168. Inclusion in this directory is not an endorsement.