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

Information source: Steno Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: nexium (Drug); nexium (Drug); Yoghurt (Dietary Supplement); placebo+placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Lise Tarnow

Official(s) and/or principal investigator(s):
Allan A. Vaag, MD, DMSc, Principal Investigator, Affiliation: Steno Diabetes Center


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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: insulin secretion

Secondary outcome: blood pressure


Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Both.


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


- Neutropenia (neutrophil count<2. 0x10/l) or anemia (hemoglobin<8mM for men or <7mM for


- 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

Locations and Contacts

Additional Information

Starting date: June 2008
Last updated: August 31, 2012

Page last updated: August 23, 2015

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