AI(I)DA Acarbose and the Subclinical Inflammation

NCT00558883 | Completed Phase 3 DMC

• 1 other identifier: AI(I)DA
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Subclinical Inflammation

Outcome Measures

Primary Outcomes (1)

• effect of treatment of leucocyte count before and after test meal

  20 weeks

Secondary Outcomes (1)

• identification of gene arrays are registered of relevant pharmacodynamic structures and metabolism ways. Histological examinations of bioptats; Blood: hsCRP, PAI1; Lymphocyte subpopulations; blood lipids, plasma glucose fasting and postprandial

  20 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

treatment with Acarbose: 2 weeks 1 x 50mg; 2 weeks 3 x 50mg; 16 weeks 3 x 100mg

Drug: acarbose

2

PLACEBO COMPARATOR

treatment with placebo: 2 weeks 1 x 50mg 2 weeks 3 x 50mg 16 weeks 3 x 100mg

Drug: acarbose

Interventions

acarbose DRUG

oral application

1; 2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead
• Technische Universität Dresden: collaborator
• Diakonissen Krankenhaus Dresden, Germany: collaborator
• University of Regensburg: collaborator

Study Sites (1)

GWT-TUD GmbH; Centre for Clinical Studies

Dresden, 01187, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Markolf Hanefeld, PhD, MD

  GWT-TUD GmbH, Centre for Clinical Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: January 1, 2005
• Study Completion: May 1, 2007
• Last Updated: April 11, 2008

Record last verified: 2008-04

Locations

DE (1)