Effects of glutamine and epigallocatechin-3-gallate on glucose tolerance, markers of inflammation, oxidative stress and procoagulant status in Type 2 diabetes mellitus
- Conditions
- diabetesType 2 diabetes mellitus10012653
- Registration Number
- NL-OMON38189
- Lead Sponsor
- Medisch Centrum Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
Patients with newly diagnosed type 2 diabetes mellitus
Ages eligible for study 30 - 80 years old
Genders eligible for study both gender
postabsorptive glucose two times >7 mmoll/L,
BMI <35kg/M2
Post absorptive glucose * 15mmol/l
Post absorptive glucose * 10 mmol/l and hyperglycemic complaints (polydipsia, polyuria and
loss of weight more than 10% in the last month)
Creatinine clearance of < 30ml/min.
Liver tests (ALAT,ASAT) > 3 times the upper level of normal
Patients known to suffer from any malignancy, an acute illness, life threatening disease, or chronic inflammatory condition at the start of the study.
Use of corticosteroids or other anti-inflammatory medication
Preexisting cardiovascular diseases or atherosclerotic diseases.
Pregnancy/breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters:<br /><br>Insulin sensitivity, by using an OGTT</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study parameters:<br /><br>Other inflammatory parameters (CRP,IL-6, IL-18, TNF-*, leucocyte NFkappaB,<br /><br>IL-4, IL-10). IL-6 en TNF-* na vol bloed LPS stimulatie.<br /><br>Oxidatieve stress parameters(Malondialdehyde, TBARS, 8-iso-prostaglandin F2*).<br /><br>Endothelial dysfunction parameters (VCAM-1, E-selectin, ICAM-1, vWF, cGMP,<br /><br>nitrate/nitrite).<br /><br>Pro-coagulant state (PAI-1, fibrinogen, P-selectin)<br /><br>Body composition (BIA).<br /><br>Weight changes</p><br>