Study In Patients With Insulin Resistance

NCT00197132 | Completed Phase 3

• 1 other identifier: 49653/375
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid management study in patients with insulin resistance.

Conditions

Insulin Resistance

Keywords

Insulin resistance vasodilatory response

Outcome Measures

Primary Outcomes (1)

• Forearm blood flow

Secondary Outcomes (1)

• 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.

Interventions

Avandia DRUG

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Clinical Trials Call Center

Nijmegen, 6525EZ, Netherlands

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2002
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)