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

Lise Tarnow

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Yoghurt; Drug: nexium; Drug: placebo+placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00699426

EudraCT: 2007-00405237

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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41 participants in 4 patient groups, including a placebo group

Nexium + Yoghurt

Active Comparator group

Treatment:

Drug: nexium

Drug: nexium

Nexium + Placebo

Placebo Comparator group

Treatment:

Drug: nexium

Drug: nexium

Placebo+ Yoghurt

Placebo Comparator group

Treatment:

Dietary Supplement: Yoghurt

placebo+placebo

Placebo Comparator group

Treatment:

Drug: placebo+placebo