MedDataX Logo

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

NCT ID: NCT00159211

Last Updated: 2007-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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/

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

type 2 diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

UMULINE NPH at bed time

Group Type ACTIVE_COMPARATOR

UMULINE NPH

Intervention Type DRUG

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

2

pioglitazone 30 mg

Group Type EXPERIMENTAL

pioglitazone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UMULINE NPH

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoires Takeda

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Agnès Hartemann-Heurtier, MDPHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19683825 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P031006

Identifier Type: -

Identifier Source: org_study_id