Abdominal Adipose Tissue Distribution in Type 2 Diabetic... | NCT00159211

Studies
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin

NCT00159211

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Nov 8, 2007Estimated

Enrollment

28Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

UMULINE NPH
pioglitazone

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inclusion was finished

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2007

Last Update Posted Date

Nov 8, 2007Estimated

Name	Class
Laboratoires Takeda	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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/

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	UMULINE NPH at bed time	Drug: UMULINE NPH
2	Experimental	pioglitazone 30 mg	Drug: pioglitazone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UMULINE NPH	Drug	UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal adipose tissue (on scan) variation at 6 month		6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agnès Hartemann-Heurtier, MDPHD	Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital		Paris		75013	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19683825	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals