Study In Patients With Insulin Resistance

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ClinicalTrials.gov Identifier: NCT00197132

Recruitment Status : Completed

First Posted : September 20, 2005

Last Update Posted : December 5, 2016

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

Fluid management study in patients with insulin resistance.

Condition or disease	Intervention/treatment	Phase
Insulin Resistance	Drug: Avandia	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Single-centre, Randomised, Double-blind, Placebo Controlled, Two 12 Week Period, Cross-over Phase III Study to Investigate the Effect of Rosiglitazone 4mg bd on the Vasodilator Response to Hyperinsulinaemia in Obese Insulin Resistant Subjects.
Study Start Date :	October 2002
Actual Primary Completion Date :	August 2003
Actual Study Completion Date :	August 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin Insulin human Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Forearm blood flow

Secondary Outcome Measures :

Insulin sensitivity, plasma volume, transcapillary escape rate, inhibition to vasodialtory response, changes in cardiac output, plasma catecholamine levels, changes in plasma hormone/markers of vascular permeability, safety and tolerability.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI 27-36 kg/m2 inclusive and at least two additional features of the metabolic syndrome or a first degree relative with a history of type 2 diabetes mellitus. BMI = Weight/height², (where weight is in kg, height in m).
Male or female aged 30 to 65 years, inclusive, at screening.
Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, Norplant Depo-Provera) or intra-uterine devices (IUD) (a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study treatment.
Willing and able to provide a signed and dated written informed consent.

Exclusion Criteria:

Subjects with type 2 diabetes mellitus defined as an HbA1c level >6.5% or a fasting plasma glucose of > 7.0 mmol/L. If fasting plasma glucose is between 6.1 and 7.0 mmol/L then a 75 g oral glucose test will be performed to exclude diabetes mellitus.
Subjects who have initiated lipid lowering therapy within the last 6 months and subjects who have increased the dose of these therapies within the last 3 months prior to study start.
Subjects who are taking Non Steroidal Anti-inflammatory Drugs, fibrates, anticoagulants or cardiovascular medications (β-blockers, nitrates, calcium antagonists, ACE inhibitors, angiotensin II antagonists, alpha blockers, diuretics, centrally acting anti-hypertensives, directly acting antihypertensives e.g., diazoxide, digoxin, anti-arrhythmics) and are unable to stop these medications for the duration of the study.
Exposure to a thiazolidinedione (TZD) or other PPAR-γ agonist (e.g. rosiglitazone, troglitazone, pioglitazone, G1262570) within the last 4 months or participation in a clinical study involving a TZD or PPAR-γ agonist.
Subjects who have required the use of any anti-diabetic medication at any time.
Use of any investigational drug within 30 days preceding the first dose of medication at the start of the study.
Subjects with a documented history of significant hypersensitivity (e.g. difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones or PPAR-γ agonists.
Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg or receiving antihypertensive therapy.
Subjects with unstable or severe angina (requiring continual therapy) or congestive heart failure.
Presence of clinically significant hepatic disease.
Clinically significant anaemia.
Subjects with creatinine clearance <40 mL/min.
Women who are lactating, pregnant or planning to become pregnant during the course of the study.
Alcohol or drug abuse within the last 6 months.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197132

Locations


Netherlands
GSK Clinical Trials Call Center
Nijmegen, Netherlands, 6525EZ

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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