AI(I)DA Acarbose and the Subclinical Inflammation

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Acarbose an alphaglucosidase inhibitor changes in a complex way the transport, the digestion and the place of glucose release and absorption. As a result the intestinal milieu, the intestinal flora and the provision of enzymes in the lower small destine are changed. This should modify immune response of intestinal wall on food and its proinflammatory effects. The small intestine is the biggest immune organ of the organism. The postprandial glucose increase could have a direct effect on low-grade inflammation. Toxic effects (glucotoxicity), activation of the immune system and low grad inflammation could be reasons of developing endothelial dysfunction and affect plaque stability. The activity of the lymphocyte immune system in the intestine would be a further component, by which acarbose could take influence on diabetogenesis and atherogenesis. The question of an enterovasal axis is one of the new research concepts. As indicators of this axis considered: leucocytes, high sensitive C-reactive protein, plasminogen activator inhibitor antigen and lymphocytes sub-populations. The effect of acarbose on these parameters in the postprandial phase are not known yet.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Collaborators: Diakonissen Krankenhaus Dresden, Germany; Technische Universität Dresden; University of Regensburg
• Treatments: Acarbose

Criteria

Inclusion criteria:

In this study patients with type 2 diabetes are included, who fulfil the following criteria:

• type 2 diabetes by WHO criteria, aged 30-75

• HbA1c ≥ 6.5 % < 8.0 % and/or 2h 75 OGTT plasma glucose ≥ 11.1 mmol/l

• fasting leucocytes count ≥ 6.2 GPt/l (median for newly diagnosed type 2 patients in RIAD) and/or hsCRP ≥ 1.0 mg/dl and < 10 mg/dl (earlier 2.8 mg/dl)

• informed consent

Exclusion criteria:

Excluded were patients with one of the following criteria:

• contraindication for acarbose

• chronic gastrointestinal disease

• prior antidiabetic treatment

• intake of statins or drugs with antiinflammatory effects

• acute or chronic inflammatory diseases

• MI or stroke < 6 months before entry

• immune diseases

• neoplasia

• diseases with acute weight loss