NCT00159211

Brief Summary

In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance. Main objective: To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas. The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 8, 2007

Status Verified

April 1, 2007

First QC Date

September 7, 2005

Last Update Submit

November 6, 2007

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Abdominal adipose tissue (on scan) variation at 6 month

    6 months

Secondary Outcomes (3)

  • Cellularity of subcutaneous adipose variation tissue at 6 month

    6 months

  • HbA1c, lipid level, adiponectin, CRP variation at 6 month

    6 months

  • inflammation gene expression in sub-cutaneous fat

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

UMULINE NPH at bed time

Drug: UMULINE NPH

2

EXPERIMENTAL

pioglitazone 30 mg

Drug: pioglitazone

Interventions

UMULINE NPHDRUG

UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l

1
pioglitazoneDRUG

30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily

2

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • BMI= 26kg/m2
  • Maximal treatment with metformin and sulfonylurea
  • HbA1c between 7.5 and 9.5%

You may not qualify if:

  • Anterior treatment with glitazones
  • Anterior treatment with insulin
  • Known heart failure
  • Hepatopathy
  • Renal filtration less than 60ml/min, Hb\<10g/dl
  • Corticoids treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital

Paris, 75013, France

Location

Related Publications (1)

  • Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clement K, Grimaldi A. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract. 2009 Oct;86(1):37-43. doi: 10.1016/j.diabres.2009.06.028. Epub 2009 Aug 15.

    PMID: 19683825DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Agnès Hartemann-Heurtier, MDPHD

    Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

May 1, 2005

Study Completion

May 1, 2007

Last Updated

November 8, 2007

Record last verified: 2007-04

Locations

FR(1)