The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.

Study Hypothesis:

1. Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c

2. Probiotics changes the gut flora and bloodpressure

3. Probiotics causes a change in inflammation and thrombosis.

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

Details

• Lead Sponsor: Lise Tarnow
• Collaborators: Chr Hansen; Chr Hansen A/S; Novo Nordisk A/S; Statens Serum Institut; Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Esomeprazole; Insulin

Criteria

Inclusion Criteria:

• Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet

• Males and females between 40 and 70 years

• HbA1c between 6,0-10,0

• Diabetes duration > 1 year

Exclusion Criteria:

• Kidney disease (s-creatinine above the upper limit of normal range).

• Liver disease (ALAT increase > 3 times the upper limit of the normal range of ALAT).

• Macroalbuminuria (urinary albumin excretion of > 300 mg/day).

• Heart failure(NYHA class lll or lV)

• Severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)

• Neutropenia (neutrophil count<2.0x10/l) or anemia (hemoglobin<8mM for men or <7mM for women.

• Alcohol abuse

• Drug abuse

• Severe organic or metabolic diseases including cancer

• C-peptide< 0,3 pmol/l

• Medicine interaction

• Treatment with insulin

• PPI or other medications for ulcus diseases

• Treatment with warfarin or other coumarin derivations

• Pregnant or breastfeeding women

• Allergy to medication used in the study

• Participants may not participate in another clinical intervention trial