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

Study Overview
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Brief Summary
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To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients. Study Hypothesis: Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c Probiotics changes the gut flora and bloodpressure Probiotics causes a change in inflammation and thrombosis.

Official Title
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The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: nexium
* Drug: nexium
* Dietary Supplement: Yoghurt
* Drug: placebo+placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nexium + Yoghurt<br> | Drug: nexium<br>* 40 mg once daily is tested together with Yoghurt<br>|
| Placebo Comparator: Nexium + Placebo<br> | Drug: nexium<br>* nexium and placebo are tested<br>|
| Placebo Comparator: Placebo+ Yoghurt<br> | Dietary Supplement: Yoghurt<br>* Yoghurt<br>|
| Placebo Comparator: placebo+placebo<br> | Drug: placebo+placebo<br>* placebo and placebo are tested.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin secretion |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 1 year |