The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes (Nexium)
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ClinicalTrials.gov Identifier: NCT00699426 |
Recruitment Status :
Completed
First Posted : June 18, 2008
Last Update Posted : September 3, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: nexium Dietary Supplement: Yoghurt Drug: placebo+placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | June 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Nexium + Yoghurt |
Drug: nexium
40 mg once daily is tested together with Yoghurt |
Placebo Comparator: Nexium + Placebo |
Drug: nexium
nexium and placebo are tested |
Placebo Comparator: Placebo+ Yoghurt |
Dietary Supplement: Yoghurt
Yoghurt |
Placebo Comparator: placebo+placebo |
Drug: placebo+placebo
placebo and placebo are tested. |
- insulin secretion [ Time Frame: 1 year ]
- blood pressure [ Time Frame: 1 year ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699426
Principal Investigator: | Allan A. Vaag, MD, DMSc | Steno Diabetes Center Copenhagen |
Responsible Party: | Lise Tarnow, professor, Steno Diabetes Center Copenhagen |
ClinicalTrials.gov Identifier: | NCT00699426 |
Other Study ID Numbers: |
EudraCT: 2007-00405237 |
First Posted: | June 18, 2008 Key Record Dates |
Last Update Posted: | September 3, 2012 |
Last Verified: | August 2012 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Esomeprazole |
Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |