Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	Laboratoires Takeda
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00159211

Purpose

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/

Condition	Intervention
Type 2 Diabetes	Drug: UMULINE NPH Drug: pioglitazone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evolution of Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin, in Association With Metformin or Sulfonylurea.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Abdominal adipose tissue (on scan) variation at 6 month [ Time Frame: 6 months ]

Secondary Outcome Measures:

Cellularity of subcutaneous adipose variation tissue at 6 month [ Time Frame: 6 months ]
HbA1c, lipid level, adiponectin, CRP variation at 6 month [ Time Frame: 6 months ]
inflammation gene expression in sub-cutaneous fat [ Time Frame: 6 months ]

Enrollment:	28
Study Start Date:	May 2005
Study Completion Date:	May 2007

Arms	Assigned Interventions
Active Comparator: 1 UMULINE NPH at bed time	Drug: UMULINE NPH UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l Other Name: UMULINE NPH
Experimental: 2 pioglitazone 30 mg	Drug: pioglitazone 30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily Other Name: pioglitazone

Detailed Description:

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.

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/

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159211

Locations

France
Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital
Paris, France, 75013

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Laboratoires Takeda

Investigators

Principal Investigator:

Agnès Hartemann-Heurtier, MDPHD

Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France

More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clément 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. Epub 2009 Aug 15.

ClinicalTrials.gov Identifier:	NCT00159211 History of Changes
Other Study ID Numbers:	P031006
Study First Received:	September 7, 2005
Last Updated:	November 6, 2007
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Assistance Publique - Hôpitaux de Paris:

type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012