Trial record 20 of 541 for:    Open Studies | "Insulin Resistance"

Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Novartis
Bayer
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00259168
First received: November 28, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
Impaired Fasting Glucose
Drug: Nateglinide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Endothelial function

Secondary Outcome Measures:
  • Metabolic function

Estimated Enrollment: 70
Study Start Date: June 2003
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

  • unstable chronic disease, acute disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259168

Contacts
Contact: Atheline Major-Pedersen, MD 35316160 atmp@heart.dk

Locations
Denmark
Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital Recruiting
Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Atheline Major-Pedersen, MD    35316160    atmp@heart.dk   
Contact: Christian Torp-Pedersen, MD, DMSc    35316159    ctp@heart.dk   
Principal Investigator: Atheline Major-Pedersen, MD         
Sub-Investigator: Nikolaj Ihlemann, MD, Phd         
Sub-Investigator: Thomas S Hermann, MD         
Sub-Investigator: Helena Dominguez, MD, Phd         
Sub-Investigator: Britt Kveiborg, MD         
Sub-Investigator: Buris Christiansen         
Sub-Investigator: Christian Rask-Madsen, MD, Phd         
Sub-Investigator: Ole L Svendsen, MD, DMSc         
Sub-Investigator: Lars Køber, MD, DMsc         
Sub-Investigator: Dorthe B Braunberg, Lab tech.         
Sub-Investigator: Christian Torp-Pedersen, MD, DMSc         
Sponsors and Collaborators
Bispebjerg Hospital
Novartis
Bayer
Investigators
Study Chair: Christian Torp-Pedersen, MD, DMSc Bispebjerg Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00259168     History of Changes
Other Study ID Numbers: 02-005/03
Study First Received: November 28, 2005
Last Updated: November 28, 2005
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee for the Counties of Copenhagen and Frederiksberg
Denmark: Danish Data agency

Keywords provided by Bispebjerg Hospital:
Postprandial endothelial function

Additional relevant MeSH terms:
Insulin Resistance
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014