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| Descriptive Information Fields | |||||
| Brief Title † | Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin | ||||
| 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. | ||||
| 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/ |
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| 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/ |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Abdominal adipose tissue (on scan) variation at 6 month [ Time Frame: 6 months ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Type 2 Diabetes | ||||
| Intervention † | Drug: UMULINE NPH Drug: pioglitazone |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 28 | ||||
| Start Date † | May 2005 | ||||
| Completion Date | May 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | France | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00159211 | ||||
| Organization ID | P031006 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators †† | Laboratoires Takeda | ||||
| Investigators † |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | April 2007 | ||||
| First Received Date † | September 7, 2005 | ||||
| Last Updated Date | November 6, 2007 | ||||
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