NCT00953498

Brief Summary

HDL from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect. The primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of HDL lipoproteins in patients with type 2 diabetes. The secondary objectives are:

  • to analyze the effect of glitazone treatment on phospholipase A2
  • to look for possible differences between the effects of pioglitazone and those of rosiglitazone
  • to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

4.4 years

First QC Date

August 5, 2009

Last Update Submit

August 30, 2013

Conditions

Type 2 Diabetes

Keywords

diabetesglitazonesHDL

Outcome Measures

Primary Outcomes (1)

  • Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins

    6 months

Secondary Outcomes (3)

  • Effect of glitazone therapy on Phospholipase A2 level

    6 months

  • Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics

    6 months

  • Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2

    6 months

Study Arms (2)

pioglitazone

ACTIVE COMPARATOR

treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)

Drug: pioglitazone

rosiglitazone

ACTIVE COMPARATOR

treatment with rosiglitazone at a dose between 4mg and 8 mg/day

Drug: rosiglitazone

Interventions

pioglitazoneDRUG

After randomization, patients will be treated by pioglitazone or rosiglitazone

Also known as: pioglitazone: ACTOS, rosiglitazone: AVANDIA
pioglitazone
rosiglitazoneDRUG

treatment with rosiglitazone at a dose between 4mg and 8 mg/day

Also known as: pioglitazone: ACTOS, rosiglitazone: AVANDIA
rosiglitazone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with type 2 diabetes treated by oral antidiabetic agents (except glitazones) and/or insulin
  • age\> 18 years
  • HbA1c \> 6.5%

You may not qualify if:

  • renal failure
  • heart failure
  • primary hyperlipidemia
  • pregnancy
  • treatment that may modify lipid metabolism (glucocorticoids, oestrogens, retinoids, HIV antiviral drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Endocrinologie-diabétologie, Hôpital du Bocage CHU

Dijon, 21000, France

Location

Related Publications (2)

  • Persegol L, Verges B, Foissac M, Gambert P, Duvillard L. Inability of HDL from type 2 diabetic patients to counteract the inhibitory effect of oxidised LDL on endothelium-dependent vasorelaxation. Diabetologia. 2006 Jun;49(6):1380-6. doi: 10.1007/s00125-006-0244-1. Epub 2006 Apr 5.

    PMID: 16596357BACKGROUND

  • Verges B, Radu L, Baillot-Rudoni S, Brindisi MC, Poussier A, Bouillet B, Petit JM, Duvillard L. Low HDL-cholesterol: a strong predictor of glycemic response to glitazone treatment in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jul;93(1):e44-8. doi: 10.1016/j.diabres.2011.04.005. Epub 2011 May 6.

    PMID: 21529978DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

PioglitazoneRosiglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bruno L Vergès, MD,PhD

    CHU Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

October 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations

FR(1)