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Effects of glutamine and epigallocatechin-3-gallate on glucose tolerance, markers of inflammation, oxidative stress and procoagulant status in Type 2 diabetes mellitus

Effects of glutamine and epigallocatechin-3-gallate on glucose tolerance, markers of inflammation, oxidative stress and procoagulant status in Type 2 diabetes mellitus - Glutamine and EGCG in type 2 diabetes mellitus

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38189
Enrollment
30
Registered
2012-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

diabetes Type 2 diabetes mellitus

Interventions

During the study no change in lifestyle will be advised. Each arm contains 30 patients who will receive for 4 weeks
Control (group1), L-glutamine 0.3-0.5 g/kg/day (group 2), EGCG 3 x 150mg/day or no intervention (group 3) and L-glutamine/EGCG (group 4). Both L-glutamine and EGCG are produced according GMP quidel

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

MeasureTime frame
Primary study parameters: Insulin sensitivity, by using an OGTT

Secondary

MeasureTime frame
Secundary study parameters: Other inflammatory parameters (CRP,IL-6, IL-18, TNF-*, leucocyte NFkappaB, IL-4, IL-10). IL-6 en TNF-* na vol bloed LPS stimulatie. Oxidatieve stress parameters(Malondialdehyde, TBARS, 8-iso-prostaglandin F2*). Endothelial dysfunction parameters (VCAM-1, E-selectin, ICAM-1, vWF, cGMP, nitrate/nitrite). Pro-coagulant state (PAI-1, fibrinogen, P-selectin) Body composition (BIA). Weight changes

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)