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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00159211
• Other study ID #: P031006
• Status: Terminated
• Phase: N/A
• First received: September 7, 2005
• Last updated: November 6, 2007
• Start date: May 2005
• Est. completion date: May 2007

Study information

• Verified date: April 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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/

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/

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
France	Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Laboratoires Takeda

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal adipose tissue (on scan) variation at 6 month		6 months
Secondary	Cellularity of subcutaneous adipose variation tissue at 6 month		6 months
Secondary	HbA1c, lipid level, adiponectin, CRP variation at 6 month		6 months
Secondary	inflammation gene expression in sub-cutaneous fat		6 months