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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159211

Enrollment

Registered

2005-09-12

Start date

2005-05-31

Completion date

2007-05-31

Last updated

2007-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes

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

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/

Interventions

DRUGUMULINE NPH

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

DRUGpioglitazone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026