Type 2 Diabetes Clinical Trial
1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and
adiposity (total fat mass and adipocyte morphology and function) in T2D women.
2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose
tissue of T2D patients.
Status | Terminated |
Enrollment | 24 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Type 2 diabetic postmenopausal women 2. glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5% 3. plasma triglycerides between 1.72-4.6 mmol/l, 4. aged between 40 -60, 5. BMI: 27-40 kg/m2 6. able to swallow tablets Exclusion Criteria: 1. patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile 2. patients with gastrointestinal disorders 3. patients treated with thiazolidinediones or insulin |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Department of Diabetes-Hotel Dieu Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of 2 month treatment on: | |||
Primary | adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity | |||
Secondary | the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects | |||
Secondary | and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes. |
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